Apparatus and methods for forming and securing gastrointestinal tissue folds

ABSTRACT

Apparatus and methods are provided for forming a gastrointestinal tissue fold by engaging tissue at a first tissue contact point and moving the first tissue contact point from a position initially distal to, or in line with, a second tissue contact point to a position proximal of the second contact point, thereby forming the tissue fold, and extending an anchor assembly through the tissue fold from a vicinity of the second tissue contact point. Adjustable anchor assemblies; as well as anchor delivery systems, shape-lockable guides and methods for endoluminally performing medical procedures, such as gastric reduction, treatment of gastroesophageal reflux disease, resection of lesions, and treatment of bleeding sites; are also provided.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.10/734,547 (Attorney Docket No. 021496-002511US), filed Dec. 12, 2003,which is a Continuation-In-Part of U.S. patent application Ser. No.10/672,375, filed Sep. 25, 2003, which claims the benefit of the filingdate of U.S. provisional patent application Ser. No. 60/500,627, filedSep. 5, 2003; and is a Continuation-In-Part of U.S. patent applicationsSer. No. 10/612,170, filed Jul. 1, 2003, and Ser. No. 10/639,162, filedAug. 11, 2003; both of which claim the benefit of the filing date ofU.S. provisional patent application Ser. No. 60/433,065, filed Dec. 11,2002. Furthermore, this application is a Continuation-In-Part of U.S.patent application Ser. No. 10/173,203, filed Jun. 13, 2002; as wellU.S. patent application Ser. No. 10/458,060, filed Jun. 9, 2003, whichis a Continuation-In-Part of U.S. patent application Ser. No.10/346,709, filed Jan. 15, 2003, and which claims the benefit of thefiling date of U.S. provisional patent application Ser. No. 60/471,893,filed May 19, 2003. Furtherstill, this application is aContinuation-In-Part of U.S. patent application Ser. No. 10/288,619,filed Nov. 4, 2002; which is a Continuation-In-Part of U.S. patentapplication Ser. No. 09/746,579, filed Dec. 20, 2000, and aContinuation-In-Part of co-pending, commonly assigned U.S. patentapplication Ser. No. 10/188,509, filed Jul. 3, 2002; which is aContinuation-In-Part of U.S. patent application Ser. No. 09/898,726,filed Jul. 3, 2001; which is a Continuation-In-Part of U.S. patentapplication Ser. No. 09/602,436, filed Jun. 23, 2000, which claims thebenefit of the filing date of U.S. provisional patent application Ser.No. 60/141,077, filed Jun. 25, 1999. All of these applications areincorporated herein by reference in their entireties.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to methods and apparatus forintraluminally forming and securing gastrointestinal (“GI”) tissuefolds. More particularly, the present invention relates to methods andapparatus for reducing the effective cross-sectional area of agastrointestinal lumen.

Morbid obesity is a serious medical condition pervasive in the UnitedStates and other countries. Its complications include hypertension,diabetes, coronary artery disease, stroke, congestive heart failure,multiple orthopedic problems and pulmonary insufficiency with markedlydecreased life expectancy.

Several surgical techniques have been developed to treat morbid obesity,e.g., bypassing an absorptive surface of the small intestine, orreducing the stomach size. These procedures are difficult to perform inmorbidly obese patients because it is often difficult to gain access tothe digestive organs. In particular, the layers of fat encountered inmorbidly obese patients make difficult direct exposure of the digestiveorgans with a wound retractor, and standard laparoscopic trocars may beof inadequate length.

In addition, previously known open surgical procedures may presentnumerous life-threatening post-operative complications, and may causeatypical diarrhea, electrolytic imbalance, unpredictable weight loss andreflux of nutritious chyme proximal to the site of the anastomosis.Further, the sutures or staples that are often used in these surgicalprocedures may require extensive training by the clinician to achievecompetent use, and may concentrate significant force over a smallsurface area of the tissue, thereby potentially causing the suture orstaple to tear through the tissue.

The gastrointestinal lumen includes four tissue layers, wherein themucosa layer is the top tissue layer followed by connective tissue, themuscularis layer and the serosa layer. One problem with conventionalgastrointestinal reduction systems is that the anchors (or staples) mustengage at least the muscularis tissue layer in order to provide a properfoundation. In other words, the mucosa and connective tissue layerstypically are not strong enough to sustain the tensile loads imposed bynormal movement of the stomach wall during ingestion and processing offood. In particular, these layers tend to stretch elastically ratherthan firmly hold the anchors (or staples) in position, and accordingly,the more rigid muscularis and/or serosa layer must be engaged. Thisproblem of capturing the muscularis or serosa layers becomesparticularly acute where it is desired to place an anchor or otherapparatus transesophageally rather than intraoperatively, since caremust be taken in piercing the tough stomach wall not to inadvertentlypuncture adjacent tissue or organs.

In view of the aforementioned limitations, it would be desirable toprovide methods and apparatus for forming gastrointestinal tissue foldsthat achieve gastric reduction by reconfiguring the GI lumen of apatient.

It would be desirable to provide methods and apparatus for forminggastrointestinal tissue folds using anchors that can be reconfiguredfrom a reduced delivery profile to an expanded deployed profile.

It also would be desirable to provide methods and apparatus for forminggastrointestinal tissue folds, wherein an anchor assembly is extendedacross stomach folds that include the muscularis and serosa tissuelayers.

It further would be desirable to provide methods and apparatus forforming gastrointestinal tissue folds, wherein the anchor assembly isdeployed in a manner that reduces a possibility of injuring neighboringorgans.

It still further would be desirable to provide methods and apparatus forforming gastrointestinal tissue folds, wherein reduced training of aclinician is required to achieve competent use of the anchor assembly.

It would be desirable to provide methods and apparatus for forminggastrointestinal tissue folds that facilitate approximation of aplurality of tissue folds.

BRIEF SUMMARY OF THE INVENTION

In view of the foregoing, it is an object of the present invention toprovide methods and apparatus for forming gastrointestinal tissue foldsthat achieve gastric reduction by reconfiguring the GI lumen of apatient.

It is another object of the present invention to provide methods andapparatus for forming gastrointestinal tissue folds using anchors thatcan be reconfigured from a reduced delivery profile to an expandeddeployed profile.

It is an additional object of this invention to provide methods andapparatus for forming gastrointestinal tissue folds in which an anchorassembly is extended across stomach folds that include the muscularisand serosa tissue layers.

It is a further object of the present invention to provide methods andapparatus for forming gastrointestinal tissue folds, wherein the anchorassembly is deployed in a manner that reduces a possibility of injuringneighboring organs.

It is yet another object to provide methods and apparatus for forminggastrointestinal tissue folds, wherein reduced training of a clinicianis required to achieve competent use of the anchor assembly.

It is an object to provide methods and apparatus for forminggastrointestinal tissue folds that facilitate approximation of aplurality of tissue folds.

These and other objects of the present invention are accomplished byproviding a catheter configured for advancement into a patient'sgastrointestinal lumen to form a gastrointestinal tissue fold. In onepreferred embodiment, the catheter has a distal region including atissue grabbing assembly adapted to engage and/or stretch a portion ofthe tissue wall of the GI lumen at a first tissue contact point. Asecond tissue contact point is then established with the tissue wall ata location initially proximal of, or in line with, the first tissuecontact point. The tissue engaged by the tissue grabbing assembly thenis moved to a position proximal of the second tissue contact point toform a tissue fold, and one or more anchor assemblies may be deliveredacross the tissue fold. Preferably, delivery of the anchor assemblyacross the tissue fold includes delivering the anchor assembly acrossthe muscularis and serosa layers of the tissue wall.

Optionally, a third tissue contact point may be established at anotherlocation initially proximal of, or in line with, the first tissuecontact point. Upon movement of the tissue engaged by the tissuegrabbing assembly to a position proximal of both the second and thirdtissue contact points, a tissue fold is formed with the second and thirdcontact points on opposing sides of the fold. The third contact pointmay provide backside stabilization upon delivery of the anchor assemblyacross the tissue fold from a vicinity of the second tissue contactpoint.

In a preferred embodiment, the tissue grabbing assembly is carried on afirst flexible tube associated with the distal region of the catheter,and the one or more anchor assemblies are delivered by an anchordelivery system disposed within a second flexible tube associated withthe distal region of the catheter. The tissue grabbing assembly maycomprise any of a number of mechanisms configured to engage the tissuewall, including a pair of jaws configured to move between open andclosed positions, a plurality of linearly translating barbs, a coilscrew, or one or more needles or hooks. The first tissue contact pointmay be moved from a tissue engagement position distal to, or in linewith, the second tissue contact point, to the tissue folding position byany of a number of mechanisms, including a hinge assembly, a treadmillassembly, or a linear pull assembly.

More preferably, the distal region of the catheter includes a bendablesection that permits the first tissue contact point to be positionedrelative to the second tissue contact point so that the tissue fold isoriented substantially perpendicular to the anchor delivery system. Inthis manner, the anchor delivery system, when deployed, pierces thetissue fold and exits into the interior of the GI lumen, rather than theexterior of the tissue wall, thereby reducing a risk of injury toadjacent organs.

The anchor assembly delivery system of the present invention preferablycomprises a needle or obturator adapted to pierce the tissue fold anddeliver an anchor assembly. In one preferred embodiment, the anchorassembly comprises a pair of rod-like anchors that are delivered througha needle in a reduced delivery profile, wherein the longitudinal axis ofthe rods is substantially parallel to the longitudinal axis of theneedle. Once ejected from the needle, the rods rotate about 90 degreesto engage the tissue. In other embodiments, the anchor assembly maycomprise anchors of various shapes delivered, for example, over theexterior of an obturator.

In a preferred embodiment of the present invention, the catheter isadapted to form a plurality of gastrointestinal tissue folds that may beapproximated. Optionally, an anchor assembly may be placed across eachtissue fold, and the plurality of tissue folds then may be approximatedby cinching the plurality of anchor assemblies together. Alternatively,an anchor assembly may be placed across a plurality of tissue folds, andthe plurality of tissue folds may be approximated by cinching the anchorassembly. As yet another alternative, a plurality of tissue folds may beapproximated prior to placement of an anchor assembly. One or moreanchor assemblies then may be placed across the approximated pluralityof tissue folds to secure the plurality in the approximated position.Multiple pluralities of tissue folds may be joined together and/orapproximated in order to perform a procedure, for example, a gastricreduction or treatment of gastroesophageal reflux disease (“GERD”).

To facilitate proper positioning, as well as visualization, of the toolsand instruments of the present invention at a treatment site within atortuous lumen or within unpredictably supported anatomy, ashape-lockable guide may be provided having a flexible state andreversibly rigidizable state. This guide may comprise an overtubethrough which instruments of the present invention, as well as anendoscope, may be advanced. As described hereinafter, exemplaryprocedures achievable when using tools of the present invention inconjunction with an endoscope include, for example, endoluminal gastricreduction and endoluminal treatment of GERD.

Methods of using the apparatus of the present invention also areprovided.

BRIEF DESCRIPTION OF THE DRAWINGS

The above and other objects and advantages of the present invention willbe apparent upon consideration of the following detailed description,taken in conjunction with the accompanying drawings, in which likereference characters refer to like parts throughout, and in which:

FIGS. 1A and 1B are, respectively, a side view and detail view ofapparatus of the present invention for forming a gastrointestinal foldin accordance with the principles of the present invention;

FIGS. 2A and 2B are side-sectional views of a tissue grabbing assemblysuitable for use with the apparatus of FIG. 1;

FIGS. 3A-3E are side views illustrating a method of using the apparatusof FIG. 1 to form a gastrointestinal fold;

FIGS. 4A-4C are side-sectional views of an anchor assembly and deliverysystem suitable for use with apparatus of the present invention;

FIGS. 5A and 5B are side-sectional views of another anchor assemblysuitable for use with apparatus of the present invention;

FIGS. 6A and 6B are side-sectional views of another alternative anchorassembly suitable for use with apparatus of the present invention;

FIGS. 7A-7C are, respectively, a schematic side-sectional view of aunidirectionally adjustable anchor assembly suitable for use withapparatus of the present invention, schematic side-sectional views ofalternative techniques for fixing the distal anchor of the assembly, anda cross-sectional view of the proximal anchor taken along section lineA-A of FIG. 7A;

FIGS. 8A and 8B are schematic cross-sectional views illustrating theunidirectional adjustment capability of the anchor assembly of FIG. 7;

FIGS. 9A-9C are schematic cross-sectional views of alternativeembodiments of the proximal anchor of the anchor assembly of FIG. 7;

FIGS. 10A and 10B are schematic cross-sectional views of an alternativeunidirectionally adjustable anchor assembly suitable for use withapparatus of the present invention;

FIGS. 11A-11C are, respectively, a schematic side-view of anotheralternative unidirectionally adjustable anchor assembly suitable for usewith the present invention, and cross-sectional views of the same takenalong section line B-B of FIG. 11A;

FIG. 12 is a schematic cross-sectional view of an alternativeunidirectionally adjustable anchor assembly comprising pivoting paddles;

FIG. 13 is a schematic cross-sectional view of an alternativeunidirectionally adjustable anchor assembly comprising spring material;

FIGS. 14A-14B are schematic side-sectional views of alternativeunidirectionally adjustable anchor assemblies comprising one-way valves;

FIGS. 15A-15C are side-sectional and detail views of alternativeunidirectionally adjustable anchor assemblies comprising slipknots;

FIGS. 16A-16C are, respectively, a schematic side-sectional view of abi-directionally adjustable anchor assembly comprising a lockingmechanism, and cross-sectional views of the same taken along sectionline C-C of FIG. 16A;

FIGS. 17A-17D are perspective views of alternative anchors suitable foruse with the anchor assemblies of the present invention;

FIGS. 18A-18D are side views of alternative apparatus for forming agastrointestinal fold;

FIG. 19 is a cross-sectional view of the apparatus of FIGS. 18A-18D;

FIGS. 20A-20D are side views of further alternative apparatus forforming a gastrointestinal tissue fold in accordance with the principlesof the present invention;

FIGS. 21A-21G are schematic side-sectional views of an anchor deliverysystem adapted for use with the adjustable anchor assemblies of FIGS.7-17, illustrating a method of delivering the unidirectionallyadjustable anchor assembly of FIG. 7 across a tissue fold;

FIGS. 22A and 22B are, respectively, a schematic side-view, partially insection, and an end-view of an alternative anchor delivery systemadapted for use with the adjustable anchor assemblies of FIGS. 7-17,wherein the proximal anchor is disposed within a separate delivery tube;

FIG. 23 is a schematic side-sectional view of an alternative anchordelivery system adapted for use with the adjustable anchor assemblies ofFIGS. 7-17, wherein both the proximal and distal anchors are loadedwithin the needle;

FIG. 24 is a schematic side-sectional view of an alternative embodimentof the anchor delivery system of FIG. 23 comprising motion limitationapparatus;

FIG. 25 is a schematic side view, partially in section of an alternativeanchor delivery system adapted to deliver a plurality of anchorassemblies;

FIG. 26 is a schematic side view of an alternative embodiment of theanchor delivery system of FIG. 25;

FIGS. 27A and 27B are, respectively, schematic isometric and side views,partially in section, of an alternative anchor delivery system adaptedto deliver a plurality of anchor assemblies via a revolver;

FIGS. 28A and 28B are side views of an alternative embodiment of theapparatus of FIG. 20 illustrating a method for simultaneously formingand approximating multiple gastrointestinal tissue folds;

FIG. 29 is an isometric view of an alternative embodiment of theapparatus of FIG. 1 for forming a gastrointestinal tissue foldcomprising backside stabilization;

FIGS. 30A-30E are a side view, partially in section, and isometric viewsillustrating a method of using the apparatus of FIG. 29 to form abackside stabilized gastrointestinal tissue fold;

FIGS. 31A-31C are side views of further alternative tissue foldingapparatus illustrating a method for forming a gastrointestinal tissuefold via a linear displacement of tissue;

FIG. 32 is a side view of an alternative embodiment of the apparatus ofFIG. 31 providing enhanced flexibility;

FIGS. 33A and 33B are side views of further alternative front andbackside stabilized linear displacement plication apparatus,illustrating a method for forming a gastrointestinal tissue fold;

FIGS. 34A and 34B are, respectively, a side view and a side view,partially in section, of still further alternative apparatusillustrating a method for forming a stabilized gastrointestinal tissuefold via a braided mesh;

FIG. 35 is a side view of illustrative shape-lockable apparatus for usewith the tissue folding and anchor delivery apparatus of the presentinvention;

FIG. 36 is a side-sectional exploded view of nestable elements of afirst embodiment of an overtube suitable for use with the shape-lockableapparatus of FIG. 35;

FIG. 37 is a side-sectional view of a distal region of the apparatus ofFIG. 35 constructed in accordance with principles of the presentinvention;

FIG. 38 is a side-sectional view of an illustrative arrangement of amechanism suitable for use in the handle of the apparatus of FIG. 35;

FIG. 39 is a side-sectional view of the detail of a wire clamping systemsuitable for use in the handle of FIG. 35;

FIGS. 40A-40D are side-views, partially in section, illustrating anexemplary method of performing endoluminal gastric reduction with asystem of tools illustratively comprising the shape-lockable apparatusof FIGS. 35-39, the plication apparatus of FIGS. 1-3, the anchorassembly of FIG. 7, the anchor delivery system of FIG. 21 and acommercially available gastroscope;

FIGS. 41A-41C are, respectively, an isometric view of a patient'sstomach after performing endoluminal gastric reduction using the methodsof FIG. 40; a cross-sectional view of the same along plane A-A in FIG.41A; and a cross-sectional view of the stomach along plane B-B in FIG.41A, prior to approximation of the pluralities of tissue folds toachieve the gastric reduction;

FIGS. 42A-42C are side-views, partially in section, illustrating anexemplary method of treating gastroesophageal reflux disease with theillustrative system of tools described with respect to FIG. 40;

FIGS. 43A and 43B are side-views, partially in section, illustrating analternative method of performing endoluminal gastric reduction utilizinga system of tools of the present invention;

FIG. 44 is a side view, partially in section, illustrating a method ofresecting a lesion or early cancer utilizing a system of tools of thepresent invention illustratively comprising a suction plicator and aresection loop; and

FIG. 45 is a side view, partially in section, illustrating a method oftreating a bleeding site utilizing a system of tools of the presentinvention.

DETAILED DESCRIPTION OF THE INVENTION

In accordance with the principles of the present invention, methods andapparatus are provided for intraluminally forming and securinggastrointestinal (“GI”) tissue folds, for example, to reduce theeffective cross-sectional area of a GI lumen. These methods andapparatus may be used to treat obesity by approximating the walls of agastrointestinal lumen to narrow the lumen, thus reducing the area forabsorption in the stomach or intestines. More particularly, the presentinvention involves endoscopic apparatus that engages a tissue wall ofthe gastrointestinal lumen, creates one or more tissue folds anddisposes one or more anchor assemblies through the tissue fold(s).Preferably, the anchor assemblies are disposed through the muscularisand/or serosa layers of the gastrointestinal lumen. In operation, adistal tip of the probe engages the tissue and then moves the engagedtissue to a proximal position relative to the catheter tip, therebyproviding a substantially uniform plication of predetermined size.

Formation of a tissue fold preferably is accomplished using at least twotissue contact points that are separated by a linear or curvilineardistance, wherein the separation distance between the tissue contactpoints affects the length and/or depth of the fold. In operation, atissue grabbing assembly engages the tissue wall in its normal state(i.e., non-folded and substantially flat), thus providing a first tissuecontact point. The first tissue contact point then is moved to aposition proximal of a second tissue contact point to form the tissuefold. An anchor assembly then may be extended across the tissue fold atthe second tissue contact point. Optionally, a third tissue contactpoint may be established such that, upon formation of the tissue fold,the second and third tissue contact points are disposed on opposingsides of the tissue fold, thereby providing backside stabilizationduring extension of the anchor assembly across the tissue fold from thesecond tissue contact point.

Preferably, the first tissue contact point is used to engage and thenstretch or rotate the tissue wall over the second tissue contact pointto form the tissue fold. The tissue fold is then articulated to aposition wherein a portion of the tissue fold overlies the second tissuecontact point at an orientation that is substantially normal to thetissue fold. An anchor then is delivered across the tissue fold at ornear the second tissue contact point.

Referring to FIG. 1, apparatus 10 of the present invention comprisestorqueable catheter 11 having distal region 12 from which first andsecond interconnected flexible tubes 13 and 14 extend, and proximalregion 15 having handle 16 and actuator 17. Catheter 11 is configuredfor insertion through a patient's mouth and esophagus into thegastrointestinal lumen. Tissue grabbing assembly 18 is disposed on thedistal end of flexible tube 13, and is coupled to actuator 17 viacontrol wire 19 that extends through flexible tube 13.

As better illustrated in FIG. 1B, flexible tubes 13 and 14 are connectedvia hinge assembly 20 that comprises link 21 attached to flexible tube13 at pivot point 22 and attached to flexible tube 14 at pivot point 23.Hinge assembly 20 prevents tissue grabbing assembly 18 from moving morethan a predetermined distance relative to distal end 24 of flexible tube14.

Still referring to FIG. 1B, flexible tubes 13 and 14 preferably includebendable sections 25 and 26, respectively. The bendable sections maycomprise, for example, a plurality of through-wall slots 27 to enhanceflexibility of the tube. Preferably, flexible tubes 13 and 14 are madefrom stainless steel with an etched or laser-cut slot pattern. Morepreferably, the slot pattern is a sinusoidal repeating pattern of slotsperpendicular to the longitudinal axis of tubes 13 and 14. Alternativeflexible patterns will be apparent to those of skill in the art.

Referring to FIGS. 2A and 2B, tissue grabbing assembly 18 comprises pairof jaws 28 a, 28 b arranged to rotate about pivot point 29 between anopen configuration (FIG. 2A) and a closed configuration (FIG. 2B).Control wire 19 is coupled via pivot point 30 to arms 31 a and 31 b.Arms 31 a and 31 b are in turn pivotally coupled to jaws 28 a and 28 b,respectively, at pivot points 32 a and 32 b. Each of jaws 28 a and 28 bpreferably includes sharpened teeth 33 disposed near its distal ends tofacilitate grasping of the tissue wall of the GI lumen.

Control wire 19 is coupled to actuator 17 of handle 16 so thattranslation of the wire within flexible tube 13 causes the jaws to openor close. In particular, urging control wire distally (as indicated byarrow A in FIG. 2A) moves pivot point 30 distally, thereby forcing thejaws to open. Urging control wire 19 proximally (as indicated by arrow Bin FIG. 2B) moves pivot point 30 proximally, thereby forcing the jaws toclose together. In alternative embodiments, tissue grabbing assembly 18may comprise a grappling hook or fork, or plurality of needles coupledto the distal end of flexible tube 13.

Flexible tube 14 is affixed to and immovable within catheter 11, whileflexible tube 13 is coupled to catheter 11 only via hinge 20.Accordingly, when control wire 19 is extended in the distal direction,flexible tube 13 is carried in the distal direction. When control wire19 is retracted in the proximal direction, flexible tube remainsstationary until jaws 28 a and 28 b close together, after which furtherretraction of control wire 19 by moving actuator 17 causes flexible tube13 to buckle in bendable region 25, as described hereinafter.

Referring now to FIGS. 1 and 3A-3E, operation of apparatus 10 isdescribed to create a tissue fold in a tissue wall of a GI lumen. InFIG. 3A, distal region 12 of catheter 11 is positioned within apatient's GI lumen transesophageally, and jaws 28 a and 28 b of tissuegrabbing assembly 18 are opened by moving actuator 17 to the distal-mostposition on handle 16. As depicted in FIG. 3B, actuator 17 may then bemoved proximally until the jaws of tissue grabbing assembly 18 engage aportion of tissue wall W at contact point P1.

Referring to FIG. 3C, after the tissue wall has been engaged at contactpoint P1, flexible tube 13 is urged proximally within catheter 11 byfurther proximal retraction of control wire 19 to stretch tissue wall Wand create tissue fold F. During this movement of flexible tube 13, link21 of hinge assembly 20 causes tissue grabbing assembly 18 to move froma position distal to distal end 24 of flexible tube 14, to a positionproximal of distal end 24 of flexible tube 14. Bendable sections 25 and26 of flexible tubes 13 and 14, respectively, accommodate any lateralmotion caused by operation of hinge assembly 20. Advantageously,formation of fold F facilitates the penetration of the tissue wall by aneedle and subsequent delivery of an anchor assembly, as describedhereinafter.

Referring to FIG. 3D, additional proximal movement of actuator 17 causesflexible tubes 13 and 14 to buckle at bendable sections 25 and 26. Hingeassembly 20 transmits force applied to flexible tube 13 via control wire19 and actuator 17 to the distal tip 24. Preferably, flexible tube 14 isconfigured so that distal tip 24 contacts, and is substantiallyperpendicular, to tissue fold F at contact point P2. As illustrated inFIG. 3E, once tissue fold F is stretched across distal tip 24 offlexible tube 14, sharpened needle or obturator 34 may be extended fromdistal tip 24 of flexible tube 14 to pierce all four layers of thetissue wall W. Sharpened needle or obturator 34 is inserted via inlet 35to flexible tube 14 on handle 16 (see FIG. 1A).

As discussed above, the GI lumen comprises an inner mucosal layer,connective tissue, the muscularis layer and the serosa layer. To obtaina durable purchase, e.g., in performing a stomach reduction procedure,the staples or anchors used to achieve reduction of the GI lumen mustengage at least the muscularis tissue layer, and more preferably, theserosa layer as well. Advantageously, stretching of tissue fold F acrossdistal tip 24 permits an anchor to be ejected through both themuscularis and serosa layers, thus enabling durable gastrointestinaltissue approximation.

As depicted in FIG. 3E, after tissue fold F is stretched across distaltip 24 of flexible tube 14 to form contact point P2 with tissue wall W,needle 34 may be extended from distal tip 24 and through tissue fold F.Because needle 34 penetrates the tissue wall twice, it exits within thegastrointestinal lumen, thus reducing the potential for injury tosurrounding organs. Once the needle has penetrated tissue fold F, ananchor assembly is ejected through distal tip 24 as describedhereinbelow.

With respect to FIGS. 4A-4C, a first embodiment of an anchor assemblysuitable for use with the apparatus of the present invention isdescribed. Anchor assembly 36 comprises T-anchor assembly having distalrod 38 a and proximal rod 38 b connected by suture 39. The preciseshape, size and materials of the anchors may vary for individualapplications. In addition, the suture material also may vary forindividual applications. By way of example, the suture material mayconsist of monofilament wire, multifilament wire or any otherconventional suture material. Alternatively, suture 39 may compriseelastic material, e.g. a rubber band, to facilitate adjustment of thedistance between the proximal and distal rods. Suture 39 extends througha pair of through-holes 40 in each rod, thereby forming a loop.Alternatively, suture 39 may be attached to the rods via an eyelet orusing a suitable adhesive. Preferably, through-holes 40 are located nearthe center of the rods 38 a and 38 b.

Referring to FIG. 4B, rods 38 a and 38 b may be delivered through needle34 (see FIG. 3E) using push rod 42. Push rod 42 is adapted to freelytranslate through flexible tube 14 and needle 34. Push rod 42 ispreferably flexible, so that it may slide through bendable section 26 offlexible tube 14. In addition, push rod 42 may include notch 43 near itsdistal end to facilitate grasping and tensioning suture 39 after anchordelivery.

During anchor delivery, the longitudinal axis of distal rod 38 a issubstantially parallel to the longitudinal axis of needle 34. However,once distal rod 38 a is ejected from needle 34, suture tension inducesthe rod to rotate approximately 90 degrees about its longitudinal axis,so that its longitudinal axis is substantially perpendicular to thelongitudinal axis of needle 35. This rotation of distal rod 38 aprevents it from being pulled back through tissue wall W.

Referring to FIG. 4C, once rod 38 a is ejected on the distal side offold F, needle 35 is retracted and push rod 42 is used to eject rod 38 bon the proximal side of tissue fold F. Like distal rod 38 a, tension inthe suture causes proximal rod 38 b to rotate about 90 degrees once itis ejected from the needle. Notch 43 in push rod 42 then may be employedto tighten suture 39 by any of a variety of mechanisms. Alternatively,suture 39 may comprise an elastic material that dynamically tightens therods against tissue fold F.

Referring now to FIG. 5A, according to other embodiments, the anchorassembly comprises a T-anchor assembly suitable to be disposed overobturator 50. More particularly, distal rod 38 a includes through-hole51 dimensioned for the passage of obturator tip 52, and obturator 50 istranslatably inserted through flexible tube 14 via inlet 35 of handle 16(see FIG. 1A). Proximal rod 38 b may be a solid rod that does notinclude a through-hole for passage of obturator 50. Alternatively,proximal rod 38 b may include a through-hole for the passage of theobturator. Preferably, obturator tip 52 is sharpened to facilitatetissue penetration.

With respect to FIG. 5B, once rod 38 a is ejected on the distal side offold F, it rotates into a position substantially parallel to tissue wallW and perpendicular to the longitudinal axis of the obturator. Obturator50 then is retracted and proximal rod 38 b is ejected from flexible tube14. More particularly, when flexible tube 14 is retracted from tissuewall W, proximal rod 38 b is pulled through distal tip 24. Proximal rod38 b then rotates substantially 90 degrees as it is ejected fromflexible tube 14 so that rod 38 b is urged against tissue wall W.

Referring to FIG. 6A, according to further embodiments, anchor assembly55 comprises a T-anchor assembly similar to the embodiment depicted inFIG. 4A. However, anchor assembly 55 includes fine wire tether 56 thatmay be twisted to maintain the tension between rods 38 a and 38 b.

With respect to FIG. 6B, a method of delivering anchor assembly 55 isdescribed. Initially, distal rod 38 a is delivered across both tissuewalls using needle 34. The needle then is retracted to release distalrod 38 a so that it engages the tissue wall. Next, needle 34 isretracted to release proximal rod 38 b, so that it too rotates intoengagement with the tissue wall. A proximal portion of the wire tetheris captured by notch 43 of push rod 42 (see FIG. 4B), and the push rodis rotated to cause proximal rod 38 b to clamp down on the tissue fold.Because wire tether 56 is twisted by rotation of push rod 42, itmaintains the desired force on the tissue walls.

Referring now to FIG. 7, a unidirectionally adjustable anchor assemblysuitable for use with apparatus of the present invention is described.Anchor assembly 60 comprises distal anchor 62 and unidirectionallyadjustable proximal anchor 64, which are connected by suture 39. Distalanchor 62 is translationally fixed with respect to suture 39. Suchfixation may be achieved in a variety of ways. For example, as seen inFIG. 7A, distal anchor 62 may comprise a pair of through-holes 63,located near the center of anchor 62 and through which suture 39 isthreaded and tied off at knot 65.

FIG. 7B provides alternative techniques for fixing the distal anchor. Asseen in FIG. 7B(i), distal anchor 62 may comprise hollow tube T havingopening O. A distal end of suture 39 is passed through opening 0 andformed into knot K, which is dimensioned such that it cannot passthrough opening 0, thereby fixing the distal anchor with respect to thesuture. In order to facilitate formation of knot K, distal anchor 62optionally may comprise distal opening DO, which is dimensioned suchthat knot K may pass therethrough. The distal end of suture 39 may bepassed through distal opening DO, knotted, and then pulled back withinhollow tube T of anchor 62 until it catches at opening O.

A drawback of the fixation technique described with respect to FIG.7B(i) is a risk of suture 39 being torn or cut due to rubbing againstopening O. In FIG. 7B(ii), hollow tube T comprises first end E to whichis connected wire loop L, which may be formed, for example from anickel-titanium alloy (“Nitinol”). Suture 39 passes through the wireloop before terminating at knot K. Knot K is dimensioned such that itcannot pass back through the wire loop. Wire loop L directs suture 39through opening 0, thereby reducing rubbing of the suture against theopening and reducing a risk of tearing or cutting of suture 39.

FIG. 7B(iii) provides yet another alternative technique for fixing thedistal anchor with respect to the suture. Distal anchor 62 againcomprises hollow tube T having opening O. Rod R is disposed within tubeT, and the ends of the tube may be either closed or crimped to rod R,such that the rod is maintained within the tube. The distal end ofsuture 39 is threaded through opening 0, around rod R, and back outopening O. The suture is then knotted at knot K, thereby fixing distalanchor 62 with respect to suture 39.

In addition to the techniques shown in FIGS. 7A and 7B, suture 39alternatively may be fixed with respect to anchor 62 by other means, forexample, via a knotted eyelet or via a suitable adhesive. Additionaltechniques will be apparent to those of skill in the art. While anchor62 is illustratively shown as a rod- or T-type anchor, any of a varietyof anchors, per se known, may be used as distal anchor 62. Exemplaryanchors are described in co-pending U.S. patent application Ser. No.10/612,170, filed Jul. 1, 2003, which is incorporated herein byreference in its entirety. Additional anchors are described hereinbelowwith respect to FIG. 17. For the purposes of the present invention,anchors and anchor assemblies should be understood to include clips forsecuring tissue, as well as suture knots and knot replacements.Furthermore, anchor assemblies may comprise multiple components that arenot initially coupled to one another; the components may be broughttogether and/or coupled within a patient at a treatment site.

Referring again to FIG. 7A, adjustable proximal anchor 64 comprisesouter cylinder 66 having first end 67 a and second end 67 b, as well asfirst opening 68 a and second opening 68 b. First and second openings 68are preferably disposed near the center of cylinder 66 and approximately180° apart. Anchor 64 further comprises first flexible rod 70 a andsecond flexible rod 70 b, both of which are disposed within outercylinder 66 and coupled to first and second ends 67 of cylinder 66. Rods70 may be formed, for example, from Nitinol or from a polymer, and maybe separated from one another by small gap G. As with the previousanchor assemblies, the precise shape, size and materials of the anchorsand suture may vary as required for specific applications.

As best seen in FIG. 7C, suture 39 passes from distal anchor 62 throughfirst opening 68 a of proximal anchor 64, around second flexible rod 70b, around first flexible rod 70 a, between rods 70 a and 70 b, and outthrough second opening 68 b. This suture winding provides aunidirectional adjustment capability that allows a length L of suture 39disposed between distal anchor 62 and proximal anchor 64 to beshortened. However, the suture winding precludes an increase in lengthL. FIG. 8 illustrate the mechanism of this unidirectional adjustmentcapability in greater detail. Optionally, suture 39 may be tied offproximal of anchor 64 at knot 69, thereby forming a proximal loop ofsuture to facilitate deployment and/or adjustment of anchor assembly 60.

In FIG. 8A, a proximally-directed force F₁ is applied to suture 39proximal of adjustable anchor 64, while anchor 64 is held stationary oris advanced distally. A portion of force F₁ is transferred throughsuture 39 to second flexible rod 70 b, which causes rod 70 b to bow,thereby increasing gap G and allowing suture 39 to freely pass betweenrods 70 a and 70 b and through proximal anchor 64, facilitatingunidirectional adjustment. When anchor 64 is held stationary whilesuture 39 is retracted proximally, distal anchor 62 retracts proximallytowards anchor 64. Alternatively, when anchor 64 is advanced distallywhile suture 39 is retracted proximally, distal anchor 62 either remainsstationary or retracts proximally towards proximal anchor 64, dependingupon a degree of distal advancement of proximal anchor 64. Regardless,length L of suture 39 disposed between anchors 62 and 64 is decreased,thereby unidirectionally adjusting a distance between the anchors.

In FIG. 8B, a distally-directed force F₂ is applied to suture 39 distalof adjustable anchor 64. Force F₂ may be applied, for example, by tissuecompressed between anchors 62 and 64. Compressed tissue stores energy ina manner similar to a compression spring and seeks to push anchors 62and 64 apart after unidirectional tightening. Force F₂ causes the loopof suture 39 around first and second rods 70 to tighten, thereby bowingboth rods inward and closing gap G such that suture 39 is frictionlocked between first and second flexible rods 70. In this manner, thelength L of suture between anchors 62 and 64 may be selectivelydecreased but cannot be increased.

As will be apparent to those of skill in the art, the magnitude of forcerequired to unidirectionally adjust length L may be altered in a varietyof ways. For example, a length, flexibility or diameter of rods 70 maybe altered. Likewise, the elasticity or diameter of suture 39 may bealtered. Initial gap G may be increased or decreased. Furtherstill, thematerials used to form rods 70 and suture 39 may be changed to altermaterial properties, such as coefficients of friction, and/or rods 70 orsuture 39 may comprise a lubricious coating. Additional methods forvarying the magnitude of force, a few of which are described hereinbelowwith respect to FIG. 9, will be apparent in view of this disclosure andare included in the present invention.

Referring now to FIG. 9, alternative anchors 64 are described. In FIG.9A, flexible rods 70 of proximal adjustable anchor 64′ are rotated withrespect to openings 68 (or vice versa). When utilizing the suturewinding described in FIGS. 7 and 8, rotation of rods 70 up to 180°clockwise progressively increases friction when force is applied toanchors 62 and 64. The magnitude of the friction lock is increased whenforce is applied in the manner described with respect to FIG. 8B.However, friction is also increased when unidirectionally adjusting thelength of suture between the proximal and distal anchors by applyingforce in the manner described with respect to FIG. 8A. Rotation of rods70 more than about 180° clockwise would cause anchor 64′ to frictionlock regardless of which direction force were applied to suture 39,thereby negating the unidirectional adjustment capability.Counterclockwise rotation of rods 70 with respect to openings 68 wouldinitially reduce friction during force application to suture 39 ineither direction. It is expected that counterclockwise rotation inexcess of about 90° would eliminate the friction lock described in FIG.8B and allow bidirectional adjustment. Continued counterclockwiserotation beyond about 450° would reverse the directions of friction lockand unidirectional adjustment, while counterclockwise rotation beyondabout 720° would result in friction lock regardless of which directionforce were applied to suture 39.

As discussed previously, openings 68 of cylinder 66 of anchor 64 arepreferably disposed approximately 180° apart from one another. However,in order to increase the friction lock force without significantlyincreasing friction during unidirectional adjustment, first opening 68 amay be rotated counterclockwise with respect to second opening 68 b (orvice versa), as seen with anchor 64″ of FIG. 9B. In this manner, firstopening 68 a is no longer in line with rods 70, while second opening 68b remains in line with rods 70. When force F₁ is applied to anchor 64″,second flexible rod 70 b is able to bow outward and increase gap G,thereby facilitating unidirectional adjustment. Likewise, when force F₂is applied to the anchor, gap G is closed more tightly upon suture 39,thereby increasing the friction lock force. If first opening 68 aalternatively were rotated clockwise with respect to the second opening,it is expected that the friction lock force would be decreased.

In FIG. 9C, proximal adjustable anchor 64′″ comprises an alternativesuture winding. Suture 39 passes from distal anchor 62 through firstopening 68 a of anchor 64′″, around second flexible rod 70 b, aroundfirst flexible rod 70 a, back around second flexible rod 70 b, betweenrods 70 a and 70 b, and out through second opening 68 b. As with thesuture winding described with respect to anchor 64 of FIGS. 7 and 8, thesuture winding illustrated in FIG. 9C provides a unidirectionaladjustment capability that allows a length L of suture 39 disposedbetween distal anchor 62 and proximal anchor 64′″to be shortened.However, this suture winding precludes an increase in length L.Additional unidirectionally adjustable suture windings will be apparentto those of skill in the art.

With reference to FIG. 10, an alternative unidirectionally adjustableanchor comprising three rods is described. Anchor assembly 80 comprisesdistal anchor 62 and proximal anchor 82. Unidirectionally adjustableproximal anchor 82 comprises outer cylinder 84 having first end 85 a andsecond end 85 b (not shown), as well as first opening 86 a and secondopening 86 b. First and second openings 86 are preferably disposed nearthe center of cylinder 84 and approximately 180° apart. Anchor 82further comprises first flexible rod 88 a, second flexible rod 88 b andthird flexible rod 88 c, all of which are disposed within outer cylinder66 and coupled to first and second ends 85 of cylinder 64. Rods 88 areseparated from one another by gaps G₁ and G₂.

Suture 39 passes from distal anchor 62 through first opening 86 a ofproximal anchor 82, around first rod 88 a, between first rod 88 a andsecond rod 88 b, between second rod 88 b and third rod 88 c, aroundthird rod 88 c, back to and around first rod 88 a, and out throughsecond opening 86 b. As seen in FIG. 10A, when force F₁ is applied tosuture 39, gaps G₁ and G₂ remain open, thereby facilitatingunidirectional adjustment/shortening of length L of suture 39 disposedbetween distal anchor 62 and proximal anchor 82. As seen in FIG. 10B,when force F₂ is applied to suture 39, gaps G₁ and G₂ close down uponsuture 39, thereby forming a friction lock that precludes an increase inlength L of suture 39.

Referring now to FIG. 11, an alternative three rod anchor assembly isdescribed. The unidirectionally adjustable anchors described hereinabovewith respect to FIGS. 7-10 all comprise rods disposed within a cylinderhaving openings for passage of a suture. The openings act to center thesuture with respect to the rods and can be used to alter magnitudes offorce applied during adjustment and friction locking, as discussedpreviously. However, such openings present a risk of tearing or cuttingthe suture as the suture slides through the openings.

As seen in FIG. 11, anchor assembly 90 comprises distal anchor 62 andproximal anchor 92. Unidirectionally adjustable proximal anchor 92comprises first flexible rod 94 a and second flexible rod 94 b, as wellas rigid rod 96, which is preferably larger in diameter than first andsecond rods 94. Flexible rods 94 are preferably fabricated from Nitinolor a polymer, while rigid rod 96 is preferably fabricated from stainlesssteel or a polymer. Alternative materials will be apparent to those ofskill in the art.

Anchor 92 further comprises first outer cylinder 98 a and second outercylinder 98 b, which are crimped to the ends of first and second rods94, and rigid rod 96. As an alternative to crimping, first and secondcylinders 98 may each comprise an end cap (not shown) to which the rodsare coupled. First and second cylinders 94 do not span a central portionof anchor 92. Flexible rods 94 are separated from one another by gap G₁,while rods 94 are separated from rigid rod 96 by gap G₂.

Anchor 92 comprises three rods, but, unlike anchor 82 of FIG. 10, suture39 is only wrapped around two of them to achieve unidirectionaladjustment. As best seen in FIGS. 11B and 11C, the illustrative suturewinding of anchor assembly 90 is similar to that described previouslywith respect to anchor assembly 60 of FIGS. 7 and 8. The break betweenfirst and second cylinders 98 acts to center suture 39 with respect tothe rods, as seen in FIG. 11A, while rigid rod 96 acts to stiffen andreduce rotation of anchor 92 as it directs suture 39 about flexible rods94.

Suture 39 passes from distal anchor 62 to proximal anchor 92, betweenrigid rod 96 and flexible rods 94, around second flexible rod 94 b,around first flexible rod 94 a, between rigid rod 96 and first flexiblerod 94 a, between flexible rods 94 a and 94 b, and out. As seen in FIG.11A, when force F₁ is applied to suture 39, flexible rods 94 are forcedapart and gap G₁ widens while gap G₂ remains substantially constant,thereby allowing unidirectional adjustment of length L of suture 39disposed between distal anchor 62 and proximal anchor 92. As seen inFIG. 11B, when force F₂ is applied to suture 39, gap G₁ closes down uponsuture 39, thereby forming a friction lock that precludes an increase inlength L of suture 39. Gap G₂ again remains substantially constant.

With reference to FIG. 12, an alternative unidirectionally adjustableanchor assembly comprising pivots is described. Anchor assembly 100comprises distal anchor 62 and proximal anchor 102. Unidirectionallyadjustable proximal anchor 102 comprises outer cylinder 103 having firstend 104 a and second end 104 b (not shown), as well as first opening 105a and second opening 105 b. First and second openings 105 are preferablydisposed near the center of cylinder 103 and approximately 180° apart.Anchor 102 further comprises first rod or paddle 106 a and second rod orpaddle 106 b, both of which are disposed within outer cylinder 103 andcoupled to the first and second ends of cylinder 103 by pins 107, whichpass through pivot holes 108. In this manner, first and second paddles106 are able to rotate about pivot holes 108. Paddles 106 may be formed,for example, from stainless steel or a polymer, and are separated fromone another by gap G. As with the previous anchor assemblies, theprecise shape, size and materials of the anchors, as well as suture 39,may vary as required for specific applications.

Suture 39 illustratively passes from distal anchor 62 through firstopening 105 a of proximal anchor 102, around second paddle 106 b, aroundfirst paddle 106 a, between paddles 106 a and 106 b, and out throughsecond opening 105 b. The placement of pivot holes 108 ensures thatapplication of force F₁, as described hereinabove, causes paddles 106 torotate apart from one another and expand gap G, thereby enablingunidirectional adjustment. Likewise, application of previously discussedforce F₂ causes paddles 106 to rotate together, thereby closing gap Gand pinching suture 39 between the paddles in a friction lock. Anincrease in the magnitude of force F₂ serves to rotate paddles 106together more tightly, thereby increasing the magnitude of the frictionlock acting upon suture 39 between the paddles. In this manner,unidirectional adjustment is achieved.

Referring now to FIG. 13, an alternative unidirectionally adjustableanchor assembly comprising spring material is described. Anchor assembly110 comprises distal anchor 62 and proximal anchor 112. Unidirectionallyadjustable proximal anchor 112 comprises outer cylinder 113 having firstend 114 a and second end 114 b (not shown), as well as first opening 115a and second opening 115 b. First and second openings 115 are preferablydisposed near the center of cylinder 113 and approximately 180° apart.Anchor 112 further comprises first rod 116 a and second rod 116 b thatare separated by gap G, as well as spring material 118, all of which aredisposed within outer cylinder 113. Spring material 118 abuts rods 116,which preferably are substantially the same length as cylinder 113, andmay either move freely within cylinder 113 or may be coupled to the ends(not shown) of cylinder 113. Spring material 118 may also move freelywithin cylinder 113 or may be coupled to the cylinder, and compriseslumen 119 having a diameter that is preferably equal to or less than thediameter of suture 39. Spring material 118 may comprise, for example, acompressible biocompatible foam, which acts as a compression spring.

Suture 39 passes from distal anchor 62 to proximal anchor 112 throughfirst opening 115 a of cylinder 113, between rods 116, through lumen 119of spring material 118, and out through second opening 115 b. Lumen 119snugly contacts suture 39 such that application of force F₁ causesfriction between the suture and the spring material to compress thespring material against the wall of cylinder 114, thereby reducing astress applied to rods 116 by spring material 118 and increasing gap Gsuch that unidirectional adjustment of length L of suture 39 disposedbetween distal anchor 62 and proximal anchor 102 may proceed.Application of force F₂ stretches spring material 118 against rods 116.thereby increasing the stress applied to the rods by the spring materialand closing gap G such that suture 39 is friction locked between rods116.

With reference to FIG. 14, alternative unidirectionally adjustableanchor assemblies comprising one-way valves are described. In FIG. 14A,anchor assembly 120 comprises distal anchor 62 and proximal anchor 122.Unidirectionally adjustable proximal anchor 122 comprises outer cylinder124 having first and second ends 125 a and 125 b, as well as firstopening 126 a and second opening 126 b. First and second openings 126are preferably disposed near the center of cylinder 124 andapproximately 180° apart. Anchor 122 further comprises first inclinedplane 128 a and second inclined plane 128 b, which are forced intoapposition by compression springs 129 a and 129 b, thereby formingone-way valve V at the junction of the two inclined planes. Inclinedplanes 128 and springs 129 are disposed within outer cylinder 124;springs 129 abut ends 125 of cylinder 124, as well as the ends of theinclined planes. Suture 39′ comprises a plurality of knots or beads Badapted to actuate one-way valve V.

Suture 39′ passes from distal anchor 62 to proximal anchor 122 throughfirst opening 126 a of cylinder 124, between inclined planes 128,through one-way valve V, and out through second opening 126 b.Application of force F₁ to suture 39′ causes a bead B to contactinclined planes 128 and gradually coax them apart by compressing springs129, thereby opening valve V and allowing the bead to pass through thevalve. Once the bead has passed through valve V, springs 129 forceinclined planes 128 back into apposition, thereby closing the valve.Continued application of force F₁ allows multiple beads to pass throughthe valve, which facilitates unidirectional adjustment of suture lengthL disposed between distal anchor 62 and proximal anchor 122. Applicationof force F₂ causes a bead B of suture 39′ to impinge upon the proximalsides of inclined planes 128. However, force transferred to the planesby the bead is perpendicular to the direction required to compresssprings 129 and urge planes 128 apart. As such, the bead B impingingupon the proximal sides of planes 128 is not able to open one-way valveV and pass back through the valve in a distal direction, therebyensuring only unidirectional adjustment, i.e. shortening, of the lengthL of suture disposed between the proximal and distal anchors.

In FIG. 14B, an alternative unidirectionally adjustable anchor having aone-way valve is described. Anchor assembly 130 comprises distal anchor62 and proximal anchor 132. Unidirectionally adjustable proximal anchor132 comprises lumen 134 having cantilevered inclined plane 136 disposedtherein, which forms one-way valve V. ‘Zip-tie’ fastener 138, having aplurality of inclined planes 139, connects proximal anchor 132 anddistal anchor 62. The plurality of inclined planes 139 are disposedabout 180° out of phase with inclined plane 136 of anchor 132.

Fastener 138 passes from distal anchor 62 to proximal anchor 132,through lumen 134 and past inclined plane 136. Inclined planes 139 offastener 138 mesh with inclined plane 136 and bend or cantilever plane136, such that planes 139 of fastener 138 may proximally pass one-wayvalve V when force F₁ is applied to the fastener, thereby enablingunidirectional adjustment of length L of fastener 138 disposed betweenthe proximal and distal anchors. Conversely, when force F₂ is applied tothe fastener, the proximal side of inclined plane 136 of anchor 132abuts the distal side of an inclined plane 139 of fastener 138, and thefastener cannot be drawn distally through proximal anchor 132, nor canthe length L of fastener disposed between the anchors be increasedsignificantly.

Referring now to FIG. 15, alternative unidirectionally adjustable anchorassemblies comprising a slipknot are described. In FIG. 15A, anchorassembly 140 comprises distal anchor 142 and proximal anchor 144.Through-holes 143 a and 143 b extend through distal anchor 142, whilethrough-holes 145 a and 145 b extend through proximal anchor 145.Preferably, through-holes 143 and 145 are located near the center ofanchors 142 and 144, respectively.

The distal end of suture 39 passes through through-hole 145 a ofproximal anchor 144 to distal anchor 142, where it passes throughthrough-hole 143 a and back through through-hole 143 b. It then extendsfrom distal anchor 142 back to proximal anchor 144, where it passesthrough through-hole 145 b of the proximal anchor. The distal end ofsuture 39 is tied off at unidirectional slipknot S, which is locatedproximal of anchor 144. FIG. 15B provides a detail view illustratingformation of slipknot S.

As will be apparent to those of skill in the art, application of forceF₁ causes suture 39 to slide through through-holes 143 and 145, anddecrease the length L of suture 39 disposed between anchors 142 and 144.Suture 39 may readily pass through slipknot S in a proximal direction,thereby facilitating unidirectional adjustment of length L. However,application of force F₂ tightens slipknot S and prohibits passage ofsuture 39 through the slipknot in a distal direction, thereby precludingan increase in length L.

FIG. 15C illustrates an alternative embodiment of anchor assembly 140wherein the slipknot is disposed within the proximal anchor. Anchorassembly 140′ comprises distal anchor 142 and proximal anchor 144′.Proximal anchor 144′ comprises hollow cylinder or tube 146 having distalopenings 147 a and 147 b, and proximal opening 148.

The distal end of suture 39 passes through proximal opening 148 into theinterior of tube 146. It then passes through distal opening 147 a ofproximal anchor 144′ to distal anchor 142, where it passes throughthrough-hole 143 a and back through through-hole 143 b. Next, suture 39extends from distal anchor 142 back to proximal anchor 144′, where itpasses through distal opening 147 b into the interior of tube 146 of theproximal anchor. The distal end of suture 39 is tied off atunidirectional slipknot S, which is disposed within tube 146 of anchor144′. Anchor assembly 140′ may be unidirectionally adjusted in a mannersimilar to that described hereinabove with respect to anchor assembly140 of FIG. 15A.

FIGS. 7-15 have illustrated anchor assemblies comprising variousmechanisms for achieving unidirectional adjustment of the distancebetween the proximal and distal anchors. These mechanisms have beenprovided solely for the sake of illustration and should in no way beconstrued as limiting. Additional mechanisms for achievingunidirectional adjustment will be apparent to those of skill in the artin view of this disclosure and are included in the present invention.Furthermore, a majority of the anchor assemblies of FIGS. 7-15 have beendescribed with the distal anchor being fixed relative to the suture, andthe proximal anchor being adjustable. However, it should be understoodthat the distal anchor may alternatively be adjustable and the proximalanchor may be fixed, and/or both anchors may be unidirectionallyadjustable, as with anchor assembly 140 of FIG. 15.

With reference now to FIG. 16, a bidirectionally adjustable anchorassembly comprising a locking mechanism is described. Anchor assembly150 comprises distal anchor 62 and proximal anchor 152. As seen in FIG.16A, bi-directionally adjustable proximal anchor 152 comprises outercylinder 153 having first end 154 a and second end 154 b, as well asfirst opening 155 a and second opening 155 b. First and second openings155 are preferably disposed near the center of cylinder 153 andapproximately 90° apart. Proximal anchor 152 further comprises tensionspring 158 disposed within outer cylinder 153.

As seen in FIG. 16B, suture 39 passes from distal anchor 62 to proximalanchor 152 through first opening 155 a, around spring 158, and outthrough second opening 155 b. Suture 39 moves freely about tensionspring 158 in either direction during application of force F₁ or forceF₂, thereby facilitating bi-directional adjustment of suture length Ldisposed between the proximal and distal anchors. However, as seen inFIG. 16C, simultaneous application of forces F₁ and F₂ with sufficientmagnitude causes suture 39 to force threads T of spring 158 apart, suchthat suture 39 is trapped between threads T and locked in position,thereby precluding further adjustment of suture length L.

The magnitude of forces required to actuate the locking mechanism ofproximal anchor 152 and lock suture 39 within threads T of spring 158may be specified/altered in a variety of ways. For example, the angularspacing of openings 155 about outer cylinder 153 may be altered, thespring constant of spring 158 may be specified, and/or spring 158 orsuture 39 may comprise a lubricious coating. Additional techniques willbe apparent to those of skill in the art. It is expected thatsimultaneous application of forces F₁ and F₂ will be encountered whenanchor assembly 150 has been deployed across a tissue fold and suturelength L has been adjusted such that the tissue fold is compressed. Amedical practitioner would then apply force F₁, while the compressedtissue fold would apply force F₂.

Although the anchor assemblies of FIGS. 10-16 have illustratively beendescribed without knots or loops of suture or fastener disposed proximalof the proximal anchor (as seen, for example, with knot 69 on suture 39of anchor assembly 60 in FIGS. 7 and 8) it should be understood thatsuch loops or knots optionally may be provided in order to facilitatedeployment and/or adjustment of the anchor assemblies. Additionally, thepreviously described anchor assemblies illustratively comprise distalrod- or T-type anchors. However, it should be understood that distalT-anchors have only been provided for the sake of illustration. Thedistal anchors (as well as the proximal anchors) may comprise any of avariety of anchors, per se known, including, for example, surgical orendoluminal clips, clips for securing tissue and suture knots or knotreplacements. Exemplary anchors are described in co-pending U.S. patentapplication Ser. No. 10/612,170, filed Jul. 1, 2003, which isincorporated herein by reference in its entirety. Furthermore, anchorassemblies may comprise multiple components that are not initiallycoupled to one another; the components may be brought together and/orcoupled within a patient at a treatment site. Additional anchors aredescribed hereinbelow with respect to FIG. 17.

Referring to FIG. 17A, articulating anchor 160 includes semi-cylindricalbase 161, rod 162 and suture 39. Rod 162 rotates about pivot point 163(as indicated by arrow 164) between an expanded position (shown in FIG.7A) and a reduced profile position, wherein rod 162 pivots within thesemi-cylindrical base 161. Articulating anchor 160 may be deliveredthrough a tissue fold using, for example, needle 34 describedhereinabove with respect to FIG. 3E. Preferably, articulating anchor 160is biased in the expanded position so that it automatically expands onceit is ejected from the needle.

With respect to FIGS. 17B and 17C the anchors of the present inventionalso may comprise one or more oblong bodies connected by at least onesuture. In FIG. 17B, anchor 165 comprises elliptical ring 166 havingsutures 39 attached at substantially opposite sides of the ring. In FIG.17C, anchor 168 comprises angle bracket 169 having a pair ofthrough-holes 170 for suture 39. In FIG. 17D, anchor 171 comprisesoblong bead 172 having a pair of through-holes 173 for suture 39. Allthree anchors 165, 168 and 171 (as well as the T-anchors describedpreviously) have a first dimension (e.g., width) that is substantiallylarger than a second dimension (e.g., height). This dimensionaldifference necessitates that anchors 165, 168 and 171 be inserted withina needle (e.g., needle 34 of FIG. 3E) in a particular orientation. Oncethe anchor is ejected through a tissue wall, tension on suture 39 forcesthe anchor to rotate so that it cannot be pulled back through the tissuewall. As will be understood by those of skill in the art, numerous otheranchors may be employed without departing from the scope of the presentinvention.

Referring now to FIG. 18A, an alternative embodiment of apparatus forforming a tissue fold, constructed in accordance with the principles ofthe present invention, is described. Apparatus 175 comprises treadmillassembly 176 disposed at distal tip 174 of flexible tube 177. Flexibletube 177 is configured to be inserted through a patient's mouth,esophagus and into the stomach. Treadmill assembly 176 comprisesconveyor 180 that circles around a pair of hubs 181 a and 181 b. Hubs181 a and 181 b rotate about axles 182 a and 182 b, respectively, andare interconnected by bracket 183. A plurality of barbs or needles 185is disposed at substantially regular intervals around the circumferenceof conveyor 180.

Flexible tube 177 preferably includes a plurality of through-wall slots186 to enhance flexibility of the tube, yet maintain torqueability.Preferably, flexible tube 177 is made from stainless steel with anetched or laser-cut slot pattern. Preferably, the slot pattern is asinusoidal repeating pattern of slots perpendicular to the longitudinalaxis of the tube. Additional and/or alternative patterns will beapparent to those of skill in the art.

Referring to FIGS. 18 and 19, transmission of motive force to treadmillassembly 176 is described. In particular, drive shaft 202 disposedwithin flexible tube 177 is coupled to a manual knob or motor located atthe proximal end of the catheter. The distal tip of drive shaft 202 isprovided with beveled gear 203 that meshes with beveled gear 204provided on axle 182 b. Accordingly, rotation of beveled gear 203 istransmitted to beveled gear 204, thereby causing axle 182 b to rotate.Axle 182 b in turn rotates hub 181 b, actuating conveyor 180. Reversingthe rotation of drive shaft 202 reverses the direction of conveyor 180.

Referring again to FIGS. 18A-18D, a method of forming a gastrointestinaltissue fold F using apparatus 175 is described. In FIG. 18A, flexibletube 177 is positioned transesophageally so that treadmill assembly 176contacts tissue wall W. Preferably, contact should be made at an anglerelative to the tissue wall W. For example, an angle of approximately 45degrees is depicted in FIG. 8A, while many other angles may be usedwithout departing from the scope of the present invention.

When treadmill assembly 176 contacts tissue wall W, needle 185 engagesthe tissue at contact point P1 as the needle moves around distal hub 181a. As depicted in FIG. 18B, as the needle moves away from distal hub 181a, tissue wall W is pulled towards proximal end 181 b, thereby forming asmall tissue fold F. As the treadmill assembly continues to turn,subsequent needles 185 engage the tissue wall so that it becomessecurely engaged to treadmill assembly 176 along the length of conveyor180.

As depicted in FIG. 18C, once tissue wall W is securely engaged totreadmill assembly 176, distal end 174 of flexible tube 177 may bearticulated in bendable section 190, thereby moving treadmill assembly176 away from tissue wall W. The articulation of flexible tube 177 maybe accomplished using a control wire and actuator disposed at theproximal end of the catheter, as previously described with respect tothe embodiment of FIG. 1. By moving the treadmill assembly away fromtissue wall W, additional tissue is pulled proximally and tissue fold Fbecomes elongated.

In FIG. 18D, tissue fold F is stretched across bendable section 190 offlexible tube 177 to create contact point P2. This permits a sharpenedneedle or obturator to be extended through one of slots 186 of bendablesection 190 and across all four layers of the tissue wall W.Advantageously, stretching of tissue fold F across bendable section 190permits an anchor to be ejected through both the muscularis and serosalayers, thus providing a durable foundation for gastrointestinal tissueapproximation. For example, needle 192 may be extended through slot 186in bendable section 190, and through the base of tissue fold F, and ananchor assembly (such as described with respect to any of FIGS. 4-17)may be ejected from needle 192 to secure the fold. Alternatively, anobturator (such as described with respect to FIGS. 5A and 5B) may beused to pierce the tissue fold at contact point P2 and deliver theanchor assembly. Treadmill assembly 176 may be disengaged from tissuewall W by reversing the rotation of proximal hub 181 b.

Referring now to FIG. 20A, a further alternative embodiment of apparatusfor forming a tissue fold in accordance with the principles of thepresent invention is described. Apparatus 200 comprises tissue grabbingassembly 18′ coupled to the distal end of a flexible tube 177′, such asdescribed with respect to the embodiment of FIG. 18. Flexible tube 177′preferably includes a plurality of through-wall slots 186′ to enhanceflexibility of the tube, yet maintain torqueability. In addition,flexible tube 177′ may be made from stainless steel with an etched orlaser-cut slot pattern, such as a sinusoidal repeating pattern of slotsperpendicular to the longitudinal axis of the tube. Alternative flexiblepatterns will be apparent.

Tissue grabbing assembly 18′ is similar to that described with respectto the embodiment of FIG. 1, and comprises a pair of jaws 28 a′, 28 b′arranged to rotate about pivot point 29′ between an open configurationand a closed configuration. Each of jaws 28 a′, 28 b′ preferablyincludes sharpened teeth 33′ disposed near its distal end to facilitategrasping tissue wall W.

With respect to FIG. 20A, tissue grabbing assembly 18′ is positionedtransesophageally adjacent to tissue wall W and jaws 28 a′, 28 b′ aremoved to the open position. Tissue grabbing assembly 18′ then is movedinto contact with tissue wall W. As depicted in FIG. 20B, tissuegrabbing assembly 18′ is used to grab the tissue wall at a first contactpoint P1. After capturing a portion of tissue wall W within jaws 28 a′,28 b′, flexible tube 177′ is urged proximally to stretch tissue wall Wand create tissue fold F.

Referring to FIG. 20C, once tissue fold F is formed, the distal end offlexible tube 177′ is articulated about bendable section 190′ to movetissue grabbing assembly 18′ away from tissue wall W. Articulation offlexible tube 177′ may be controlled using an actuator disposed at theproximal end of the catheter, thus causing tissue fold F to becomeelongated.

In FIG. 20D, tissue fold F is shown stretched across bendable section190′ so that a sharpened needle or obturator may be extended from one ofslots 186′ in bendable section 190′ and across all four layers of thetissue wall W. Needle 192′ then may be extended from slot 186′ inbendable section 190′ through contact point P2 and tissue fold F. Ananchor assembly (e.g., as described with respect to any of FIGS. 4-17)then may be ejected from needle 192′ to secure the fold. Alternatively,an obturator (e.g., as described with respect to FIGS. 5A and 5B) may beused to pierce the tissue fold at contact point P2 and deliver theanchor assembly.

With reference now to FIG. 21, an anchor delivery system adapted for usewith the adjustable anchor assemblies of FIGS. 7-17 is described. InFIG. 21, the anchor delivery system is illustratively shown in use withanchor assembly 60 of FIG. 7, but this should in no way be construed aslimiting. Also, the delivery system of FIG. 21 may be used inconjunction with apparatus for forming a tissue fold, such as apparatus10, 175 and 200 described previously, or alternative apparatus describedhereinafter, in order to anchor the tissue fold. Alternatively, thedelivery system may be used for any other application, or in conjunctionwith any other apparatus, requiring delivery of an anchor assembly.

In FIG. 21A, a distal region of anchor delivery system 250 is disposedadjacent tissue fold F in tissue wall W. Anchor delivery system 250comprises flexible delivery tube 252 having lumen 253. Flexible deliverytube 252 may be configured for insertion through a patient's mouth andesophagus into a gastrointestinal lumen, such as the stomach. Lumen 253of delivery tube 252 preferably has a diameter of less than about 5 mm,and even more preferably has a diameter of about 2-3 mm. Flexibledelivery tube 252 preferably includes a plurality of through-wall slots254 to enhance flexibility of the tube, yet maintain torqueability.Slots 254 may form bendable section 255. Preferably, flexible deliverytube 252 is made from stainless steel with an etched or laser-cut slotpattern. The slot pattern is preferably a sinusoidal repeating patternof slots perpendicular to the longitudinal axis of the tube. Additionaland/or alternative patterns will be apparent.

Anchor delivery system 250 further comprises delivery needle 260. Needle260 preferably has a length of less than 2 cm, and even more preferablyhas a length of about 1.5 cm. Needle 260 preferably comprises sharpeneddistal tip 262, lumen 264, slot 266 extending proximally from distal tip262, and proximal eyelet 268.

Lumen 264 of needle 260 is dimensioned such that a distal anchor may bedisposed therein. As discussed previously, anchor delivery system 250 isillustratively described in conjunction with anchor assembly 60 of FIG.7. In FIG. 21A, distal anchor 62 is disposed within lumen 264 of needle260. Suture 39 passes through slot 266 of the needle as the sutureextends from distal anchor 62 to proximal anchor 64. Needle 260preferably is disposed within lumen 253 of flexible delivery tube 252distal of bendable section 255, while proximal anchor 64 preferably isdisposed within delivery tube 252 proximal of bendable section 255.

In this arrangement, distal anchor 62 may be deployed through needle 260while the bendable section is actuated or bent, e.g., when anchordelivery system 250 is used in conjunction with previously describedplication apparatus. Proximal anchor 64 subsequently may be advancedthrough bendable section 255 after the bendable section has once againbeen straightened. The distance, or length, of suture 39 extendingbetween distal anchor 62, which is disposed distal of the bendablesection, and proximal anchor 64, which is disposed proximal of thebendable section, is preferably greater than or equal to about 2 cm, andis even more preferably greater than or equal to about 4 cm.

Needle 260 is proximally coupled to needle pushrod 270, whichfacilitates translation of the needle beyond a distal end of flexibledelivery tube 252. Needle pushrod 270 extends to a control actuatordisposed at a proximal end of anchor delivery system 250 (not shown).Pushrod 270 optionally may be spring-loaded (not shown), for example, tofacilitate puncture of tissue wall W and passage of needle 260 throughtissue fold F.

Anchor delivery system 250 further comprises anchor pushrod 280, whichis removably disposed through eyelet 268 of needle 260, and isconfigured to eject distal anchor 62 from lumen 264 of needle 260. Aswith needle pushrod 270, anchor pushrod 280 extends to a controlactuator disposed at a proximal end of anchor delivery system 250 (notshown). The actuators controlling pushrods 270 and 280 are preferably atleast partially coupled so that relative motion between the two pushrodscan be limited and/or eliminated, as needed. Pushrod 280 passes throughthe proximal loop of suture formed by knot 69 on suture 39, such thatthe suture loop is threaded between needle pushrod 270 and anchorpushrod 280. This facilitates unidirectional adjustment of the length ofsuture disposed between distal anchor 62 and proximal anchor 64, asdescribed hereinbelow.

In FIG. 21B, pushrods 270 and 280 are simultaneously distally advancedwith sufficient force, e.g., via spring-loading, such that sharpeneddistal tip 262 of needle 260 pierces tissue wall W and is advancedacross fold F. Bendable section 255 of flexible delivery tube 252optionally may be bent during advancement of the needle, as describedpreviously with respect to the plication apparatus (see FIG. 3E). Anchorpushrod 280 is then advanced distally with respect to needle pushrod 270and needle 260, such that it abuts distal anchor 62 and ejects theanchor from lumen 264 of needle 260 on the distal side of tissue fold F,as seen in FIG. 21C. Suture 39 likewise is ejected from slot 266 anddisposed across fold F.

During delivery, the longitudinal axis of distal anchor 62 issubstantially parallel to the longitudinal axis of needle 260. However,once anchor 62 has been ejected from needle 260, suture tension inducesthe anchor to rotate approximately 90° about its longitudinal axis, sothat its longitudinal axis is substantially perpendicular to thelongitudinal axis of needle 260. This rotation of distal anchor 62prevents it from being pulled back through tissue wall W. One or bothends of anchor 62 may be flared outward (not shown) to facilitate suchrotation upon contact with the tissue wall.

In FIG. 21D, anchor pushrod 280 is retracted proximally within lumen 264of needle 260, the needle is retracted within flexibly delivery tube 252via pushrod 270, and then delivery system 250 is retracted proximallyacross tissue fold F. Distal anchor 62 is disposed on the distal side ofthe tissue fold, suture 39 extends through the fold, and proximal anchor64 is disposed on the proximal side of the fold within delivery tube252. If bendable section 255 were flexed during deployment of distalanchor 62 (see FIG. 3E), it is straightened to facilitate delivery ofthe proximal anchor.

Delivery tube 252 is then retracted proximally with respect to pushrods270 and 280, causing needle 260 to exit lumen 253 of the delivery tubeon the proximal side of tissue fold F, thereby providing space forproximal anchor 64 to exit the lumen. Next, delivery tube 252 or thefull delivery system 250 is retracted, such that proximal anchor 64 isejected from delivery tube lumen 253, as seen in FIG. 21E. Delivery tube252 is then re-advanced and/or pushrods 270 and 280 are simultaneouslyretracted, such that needle 260 is repositioned within lumen 253 of thedelivery tube.

Flexible delivery tube 252 is advanced with respect to needle 260, suchthat it pushes proximal anchor 64 distally. The proximal suture loopformed by knot 69 on suture 39 catches against the proximal end ofneedle 260 and anchor pushrod 280, which pulls distal anchor 62 tautagainst tissue fold F, as seen in FIG. 21F. Continued advancement ofdelivery tube 252 unidirectionally adjusts, i.e. shortens, length L ofsuture 39 disposed between distal anchor 62 and proximal anchor 64,while forcing proximal anchor 64 against the tissue fold and firmlyanchoring the fold between the proximal and distal anchors.

Once length L has been adjusted such that anchor assembly 60 firmlyanchors tissue fold F in position, anchor pushrod 280 may be retractedproximally with respect to needle pushrod 270 and needle 260, such thatthe distal end of anchor pushrod 280 is proximally retracted througheyelet 268 and out of needle 260. As seen in FIG. 21G, the suture loopformed by knot 69 on suture 39 slips off the distal end of anchorpushrod 280, removing anchor assembly 60 from anchor delivery system250. Anchor delivery system 250 may then be removed from the patient.Alternatively, needle 260, needle pushrod 270 and anchor pushrod 280 maybe proximally retracted and removed from lumen 253 of anchor deliverytube 252. An additional anchor assembly 60 may then be reloaded withinneedle 260 and delivery tube 252 from a proximal end of the deliverytube, while a distal end of the delivery tube remains within thepatient. The additional anchor assembly may, for example, be placedacross an additional tissue fold.

Delivery system 250 optionally may comprise cutting apparatus (notshown) for removing the portion of suture extending proximally ofproximal anchor 64 post-adjustment. Alternatively, secondary apparatusmay be provided to remove such proximal length of suture. As yet anotheralternative, the unneeded length of suture may be left within thepatient post-procedure.

In order to decrease the number of steps required to deliver and adjustanchor assembly 60, once distal anchor 62 has been deployed, as in FIG.21C, the entire anchor delivery system 250 may be retracted proximally,such that needle 260 is retracted across tissue fold F while stilldisposed outside of delivery tube lumen 253. This is in contrast to themethod described with respect to FIG. 21D, wherein the needle isdisposed within the delivery tube prior to retraction across the tissuefold. Continued proximal retraction of anchor delivery system 250 ordelivery tube 252 deploys proximal anchor 64 from delivery tube lumen253. Anchor assembly 60 then may be unidirectionally adjusted, asdescribed previously.

Anchor delivery system 250 advantageously provides a medicalpractitioner with significant control during all steps of anchorassembly deployment. Such control affords the medical practitioner ampleopportunity to abort deployment of the anchor assembly. Upon passage ofneedle 260 across tissue fold F, as seen in FIG. 21B, the medicalpractitioner may decide to retract the needle across the fold and notlaunch the distal anchor. Alternatively, after deployment of the distalanchor 62, as seen in FIG. 21D, the medical practitioner may decide notto deploy the proximal anchor and may sever the suture connecting theproximal and distal anchors. The distal anchor then would simply passharmlessly through the patient's digestive system. As yet anotherexample, the medical practitioner may decide not to cinch the proximaland distal anchors post-deployment, thereby leaving the anchors in placewithout securing tissue fold F. Furtherstill, the medical practitionermay reverse cinching or cut the anchor assembly post-deployment, therebyreversing tissue fold formation.

As will be apparent to those of skill in the art, when anchor deliverysystem 250 is used in conjunction with previously described apparatus10, 175 or 200, to place an anchor assembly across fold F formed by saidapparatus, flexible delivery tube 252 may either comprise or be advancedthrough flexible tube 14, 177 or 177′, of apparatus 10, 175 or 200,respectively. Likewise, needle 260 may comprise needle 34, 92 or 92′, ofapparatus 10, 175 or 200, respectively. Needle 260 alternatively maycomprise obturator 50 of FIG. 5. As will be apparent, components ofanchor delivery system 250 may also comprise or be advanced throughcomparable components of alternative tissue folding apparatus describedhereinafter.

Referring now to FIG. 22, an alternative anchor delivery system isdescribed. As with anchor delivery system 250 of FIG. 21, anchordelivery system 300 of FIG. 22 is adapted for use with the adjustableanchor assemblies of FIGS. 7-17. In FIG. 22, the anchor delivery system300 is illustratively shown in use with anchor assembly 60 of FIG. 7,but this should in no way be construed as limiting. Also, deliverysystem 300 may be used in conjunction with apparatus for forming atissue fold, such as apparatus 10, 175 and 200 described previously, oralternative apparatus described hereinafter, in order to anchor thetissue fold. Alternatively, the delivery system may be used for anyother application, or in conjunction with any other apparatus, requiringdelivery of an anchor assembly.

FIG. 22A illustrates a distal region of anchor delivery system 300.System 300 comprises flexible delivery tube 302 having lumen 303.Flexible delivery tube 302 may be configured for insertion through apatient's mouth and esophagus into a gastrointestinal lumen, such as thestomach. Flexible delivery tube 302 preferably includes a plurality ofthrough-wall slots 304 to enhance flexibility of the tube, yet maintaintorqueability. Slots 304 may form bendable section 305. Preferably,flexible delivery tube 302 is made from stainless steel with an etchedor laser-cut slot pattern. The slot pattern is preferably a sinusoidalrepeating pattern of slots perpendicular to the longitudinal axis of thetube. Additional/alternative patterns will be apparent to those of skillin the art.

Flexible delivery tube 302 further comprises end region 306, which iscoupled to anchor tube 307 having lumen or bore 308. As best seen inFIG. 22B, Lumen 308 of anchor tube 307 communicates with lumen 303 Dfdelivery tube 302 via through-slot 309. Proximal anchor 64 is disposedwithin anchor tube 307, while distal anchor 62 is disposed within needle260′, which sits within delivery tube 302.

Suture 39 passes out of needle 260′ from distal anchor 62 through slot266′. It then crosses from flexible delivery tube 302 to anchor tube 307via through-slot 309. After passing through proximal anchor 64, suture39 is passed back to delivery tube 302 via the through-slot, and isthreaded around anchor pushrod 280′, such that the loop of suture formedby knot 69 on suture 39 is disposed between needle pushrod 270′ andanchor pushrod 280′.

Needle 260′, needle pushrod 270′ and anchor pushrod 280′ aresubstantially the same as needle 260 and pushrods 270 and 280,respectively, which are described hereinabove with respect to anchordelivery system 250 of FIG. 21. Furthermore, anchor assembly 60 may bedelivered from and adjusted by anchor delivery system 300 in a mannersimilar to that described hereinabove with respect to system 250.

In FIG. 22A, anchor tube 307 of anchor delivery system 300 isillustratively shown as a relatively short tube having lumen or bore 308adapted for disposal of proximal anchor 64 therein. However, it shouldbe understood that anchor tube 307, lumen 308 and/or through-slot 309alternatively may extend all or part of the way to a proximal end offlexible delivery tube 302 of delivery system 300. Advantageously, suchan arrangement facilitates loading of anchor assembly 60 from a proximalend of the anchor delivery system, e.g., for reloading of anchordelivery system 300 while a distal region of the system is disposedwithin a patient. Such an arrangement also may simplify manufacturing ofthe system.

Anchor delivery system 300 illustratively has been described with asingle anchor assembly 60 disposed therein. However, it should beunderstood that a plurality of anchor assemblies may be loaded withindelivery system 300, thereby facilitating delivery of multiple anchorassemblies across different points of a tissue fold, across different(e.g., adjacent) tissue folds, or across other tissue structures. Theplurality of distal anchors 62 preferably are loaded within needle 262′of flexible delivery tube 302, while the plurality of proximal anchors64 preferably are loaded within lumen 308 of anchor tube 307.

An advantage of anchor delivery system 300, as compared to system 250 ofFIG. 21, is that both the proximal and distal anchors are located distalof the bendable section of the delivery tube during delivery. Thisreduces an initial length of suture that must be disposed between theanchors, thereby reducing a length of unneeded suture extendingproximally of the proximal anchor post-delivery and adjustment. It alsosimplifies delivery by allowing both the proximal and distal anchors tobe delivered while the bendable section of the delivery tube is bent.Additionally, placement of the proximal anchor in a separate anchor tubeeliminates a need to eject the needle from the flexible delivery tube onthe proximal side of a tissue fold in order to deploy the proximalanchor, thereby reducing a risk of accidental tissue puncture with theneedle.

With reference to FIG. 23, another alternative anchor delivery system isdescribed. As with anchor delivery systems 250 and 300 of FIGS. 21 and22, respectively, anchor delivery system 400 of FIG. 23 is adapted foruse with the adjustable anchor assemblies of FIGS. 7-17. Anchor deliverysystem 400 is illustratively shown in use with anchor assembly 60 ofFIG. 7, but this should in no way be construed as limiting. Also,delivery system 400 may be used in conjunction with apparatus forforming a tissue fold, such as apparatus 10, 175 and 200 describedpreviously, or alternative apparatus described hereinafter, in order toanchor the tissue fold. Alternatively, delivery system 400 may be usedfor any other application, or in conjunction with any other apparatus,requiring delivery of an anchor assembly.

FIG. 23 illustrates a distal region of anchor delivery system 400.System 400 comprises flexible delivery tube 402 having lumen 403.Flexible delivery tube 402 may be configured for insertion through apatient's mouth and esophagus into a gastrointestinal lumen, such as thestomach. Flexible delivery tube 402 preferably includes a plurality ofthrough-wall slots to enhance flexibility of the tube, yet maintaintorqueability. The slots may form bendable section 405.

Anchor delivery system 400 further comprises delivery needle 260″, whichis disposed within lumen 403 of flexible delivery tube 402 distal ofbendable section 405 during delivery. As discussed previously, anchordelivery system 400 is illustratively described in conjunction withanchor assembly 60 of FIG. 7. Needle 260″ preferably has a lengthsufficient for both distal anchor 62 and proximal anchor 64 of anchorassembly 60 to be disposed therein; for example, needle 260″ preferablyhas a length of less than about 5 cm, and even more preferably has alength of about 3 cm. Except for an increase in length, needle 260″ issubstantially the same as needle 260 of FIG. 21.

In FIG. 23, both distal anchor 62 and proximal anchor 64 are disposedwithin lumen 264″ of needle 260″. Suture 39 passes through and backthrough slot 266″ of the needle as the suture extends from distal anchor62 to proximal anchor 64. Alternatively the length of suture between theproximal and distal anchors may be disposed within the needle duringdelivery. Advantageously, both the proximal and distal anchors of anchorassembly 60 may be deployed through needle 260″ while bendable section405 is actuated or bent, e.g., while anchor delivery system 400 is usedin conjunction with previously described plication apparatus.

Needle 260″ is proximally coupled to flexible needle pushtube 420, whichfacilitates translation of the needle beyond a distal end of flexibledelivery tube 402. As will be apparent to those of skill in the art,needle 260″ and needle pushtube 420 optionally may be manufactured as asingle piece. Needle pushtube 420 comprises lumen 422, as well as skive424 that communicates with lumen 422. Needle pushtube 420 extends to acontrol actuator (not shown), which may be spring-loaded, disposed at aproximal end of anchor delivery system 400.

Anchor pushrod 280″, which is substantially the same as anchor pushrod280 described previously, is removably disposed within lumen 422 ofneedle pushtube 420 distal of skive 424. As with pushtube 420, anchorpushrod 280″ extends to a control actuator (not shown) disposed at aproximal end of the anchor delivery system. Suture 39 proximally extendsfrom proximal anchor 64 through slot 266″ of needle 260″, through skive424 and within lumen 422 of needle pushtube 420, around anchor pushrod280″ and out through skive 424 to knot 69. The proximal loop of sutureformed by knot 69 is trapped around pushrod 280″ and within lumen 422 ofthe needle pushtube, thereby facilitating unidirectional adjustment ofthe length of suture disposed between distal anchor 62 and proximalanchor 64. As an alternative to the proximal loop of suture, knot 69 maybe formed on the proximal end of suture 39, such that the knot istrapped between anchor pushtube 280″ and needle pushrod 420 (see knot Kof FIG. 24).

Anchor assembly 60 may be delivered, deployed and adjusted by anchordelivery system 400 in a manner similar to that described hereinabovewith respect to system 250 of FIGS. 21, with a few alterations.Specifically, during deployment of distal anchor 62, anchor pushrod 280″is advanced against proximal anchor 64, which in turn advances in-linedistal anchor 62. The pushrod is advanced a sufficient distance withrespect to needle 260″ to eject the distal anchor from needle lumen264″, but not so far as to also prematurely eject proximal anchor 64.Motion limitation apparatus may be provided to ensure that the distalanchor is not prematurely ejected. Exemplary motion limitation apparatusis described hereinbelow with respect to FIG. 24; additional apparatus,per se known, will be apparent.

In order to eject proximal anchor 64 from lumen 264″ of needle 260″,either the needle is retracted until length L of suture 39 disposedbetween the proximal and distal anchors is pulled taut and pulls theproximal anchor out of the needle lumen, or anchor pushrod 280″ isadvanced a sufficient distance within the lumen of needle 260″ to ejectthe proximal anchor from the lumen (or a combination thereof).Additionally, in order to release anchor assembly 60 from anchordelivery system 400 post-delivery and adjustment, anchor pushrod 280″ isretracted proximal of skive 424 such that the loop of suture 39 formedby knot 69 is no longer trapped within lumen 422 of needle pushrod 420.Upon deployment of anchor assembly 60, delivery system 400 may beremoved from the patient. Alternatively, needle 260″ and needle pushrod420, as well as anchor pushrod 280″, may be removed from the patient,reloaded with a new anchor assembly, and re-advanced through flexibledelivery tube 402 for deployment of additional anchors withoutnecessitating removal of delivery tube 402 from the patient.

A significant advantage of anchor delivery system 400, as compared tosystem 250 of FIG. 21, is that both the proximal and distal anchors aredisposed distal of bendable section 405 of flexible delivery tube 402. Asignificant advantage of anchor delivery system 400, as compared tosystem 300 of FIG. 22, is that both the proximal and distal anchors aredisposed within needle 260″, thereby eliminating a need for an anchortube and reducing a profile of the system.

Referring now to FIG. 24, an alternative embodiment of anchor deliverysystem 400 is described comprising motion limitation apparatus. Anchordelivery system 400′ is substantially the same as system 400, exceptthat needle pushtube 420′ comprises two skives: motion limitation skive430 and unidirectional adjustment skive 432, both of which communicatewith lumen 422′ of the needle pushrod. Suture 39 proximally extends fromproximal anchor 64, through motion limitation skive 430 and within lumen422′ between anchor pushrod 280″ and needle pushtube 420′. Suture 39exits skive 430 and is tied off at motion limitation knot K, which istrapped at skive 430 by anchor pushrod 280″. Suture 39 then continuesproximally to unidirectional adjustment skive 432 and the proximal loopof suture formed by knot 69, which is trapped at skive 432 aroundpushrod 280″.

A length of suture extending between proximal anchor 64 and knot K isspecified such that distal anchor 62 may exit lumen 264″ of needle 260″,but proximal anchor 64 cannot exit while knot K is trapped at skive 430by anchor pushrod 280″. For example, during delivery of anchor assembly60 across a tissue fold, advancement of pushrod 280″ advances proximalanchor 64, which in turn advances in-line distal anchor 62 until thedistal anchor is ejected from needle lumen 264″ on the distal side ofthe tissue fold. Knot K limits a distance anchor pushrod 280″ may beadvanced and ensures that proximal anchor 64 is not prematurelydeployed.

Once anchor delivery system 400′ is again disposed on the proximal sideof the tissue fold, anchor pushrod 280″ is retracted proximal of motionlimitation skive 430, thereby allowing knot K to escape from skive 430and facilitating deployment of proximal anchor 64. Proximal anchor 64may be deployed by either retracting needle 260″ until the length ofsuture between the two anchors is pulled taut and pulls the proximalanchor out of the needle, or by re-advancing pushrod 280″ to push theproximal anchor out of the needle.

The anchor assembly may then be unidirectionally adjusted via the sutureloop trapped at skive 232, as described previously. After adjustment hasbeen completed, anchor pushrod 280″ is retracted proximal ofunidirectional adjustment skive 432, thereby allowing the loop of sutureformed by knot 69 of suture 39 to escape from skive 432. As with anchordelivery systems 250 and 400 described previously, upon deployment ofthe anchor assembly, system 400′ may be removed from the patient, or maybe reloaded while flexible tube 402 remains in the patient. Asignificant advantage of anchor delivery system 400′, as compared tosystem 400 of FIG. 23, is that motion limitation skive 430 reduces arisk of premature deployment of proximal anchor 64.

With reference to FIG. 25, yet another alternative anchor deliverysystem is described. Anchor delivery system 500 is adapted to delivermultiple adjustable anchor assemblies without necessitating reloading orremoval from a patient. Delivery system 500 may be used in conjunctionwith apparatus for forming a tissue fold or may be used for any otherapplication, or in conjunction with any other apparatus, requiringdelivery of an anchor assembly. In FIG. 25, anchor delivery system 500is illustratively loaded with multiple anchor assemblies 60 of FIG. 7,but this should in no way be construed as limiting.

FIG. 25 illustrates a distal region of anchor delivery system 500.System 500 comprises flexible delivery tube 510, flexible needle tube520, anchor pushrod 530 and skive rod 540. Delivery tube 510, which issubstantially the same as delivery tube 402 described previously,comprises lumen 511 and optional bendable section 512. Needle tube 520comprises delivery needle 522, anchor lumen 523 and skive bore 524.Lumen 523 extends through needle tube 520 from its proximal end toneedle 522, and anchor pushrod 530, as well as anchor assemblies 60, isdisposed within the lumen. Bore 524 preferably terminates just proximalof needle 522; skive rod 540 is disposed within the bore. For ease ofmanufacturing, bore 524 optionally may be replaced with a lumen (notshown) that extends all the way to needle 522.

Needle tube 520 further comprises two through-slots and two skives:first motion limitation through-slot 526 a, first unidirectionaladjustment skive 528 a, second motion limitation through-slot 526 b, andsecond unidirectional adjustment skive 528 b. The skives andthrough-slots all communicate with skive bore 524. Through-slots 526further communicate with anchor lumen 523 and provide passagewaysbetween the anchor lumen and skive bore 524. Skives 528 furthercommunicate with the exterior of needle tube 520 and provide passagewaysbetween the exterior and skive bore 524.

As discussed previously, anchor delivery system 500 is illustrativelyshown loaded with anchor assemblies 60. First anchor assembly 60 a andsecond anchor assembly 60 b are disposed within anchor lumen 523, withassembly 60 a disposed distal of assembly 60 b. Anchor pushrod 530 isdisposed proximal of second assembly 60 b within lumen 523.

First suture 39 a of first anchor assembly 60 a proximally extendswithin lumen 523 from first distal anchor 62 a to and through firstproximal anchor 64 a. Suture 39 a then extends from anchor lumen 523 toskive bore 524 via first motion limitation through-slot 526 a. Suture 39a loosely encircles skive rod 540 and is tied off to itself at firstmotion limitation knot K_(1A), such that the loop of suture formed byknot K_(1A) is trapped about skive rod 540. A length of suture disposedbetween first proximal anchor 64 a and first motion limitation knotK_(1A) is sufficient to allow deployment of first distal anchor 62 afrom lumen 523 of needle tube 520, but is not long enough to allowdeployment of first proximal anchor 64 a from the lumen. Rather, thelength of suture is pulled taut with the loop formed by knot K_(1A)abutting first through-slot 526 a and trapped about skive rod 540. Inthis manner, the suture loop formed by knot K_(1A) provides motionlimitation when disposed about skive rod 540. Skive rod 540 may betranslated relative to the suture loop to release the loop from the rodafter deployment of first distal anchor 62 a.

From knot K_(1A), first suture 39 a continues proximally to firstunidirectional adjustment skive 528 a. Suture 39 a then once againloosely encircles skive rod 540 and is tied off to itself at firstunidirectional adjustment knot K_(1B). While disposed about skive rod540 at first skive 528 a, the loop of suture formed by knot K_(1B) maybe used to unidirectionally adjust first anchor assembly 60 apost-deployment, as described hereinabove. A length of suture disposedbetween first proximal anchor 64 a and first unidirectional adjustmentknot K_(1B) is sufficient to enable deployment of the anchor from lumen523 of anchor tube 520.

Second suture 39 b of second anchor assembly 60 b couples second distalanchor 62 b and second proximal anchor 64 b to second motion limitationthrough-slot 526 b and second unidirectional adjustment skive 528 b in amanner similar to that described with respect to first suture 39 a offirst anchor assembly 60 a. The loop of suture formed by second motionlimitation knot K_(2A) precludes premature deployment of second proximalanchor 64 b, while the loop of suture formed by second unidirectionaladjustment knot K_(2B) enables adjustment of a length of suture disposedbetween second distal anchor 62 b and second proximal anchor 64 b.

Anchor assemblies 60 a and 60 b may be delivered from, and adjusted by,anchor delivery system 500 in a manner similar to that describedhereinabove with respect to system 400′ of FIG. 24, with a fewalterations. Specifically, during deployment of first distal anchor 62a, anchor pushrod 530 is advanced against second proximal anchor 64 b,which in turn advances in-line second distal anchor 62 b and in-linefirst proximal anchor 64 a. The pushrod is advanced a sufficientdistance with respect to needle tube 520 to eject first distal anchor 62a from anchor lumen 523.

Additional advancement of pushrod 530 causes the suture loop formed byfirst motion limitation knot K_(1A) to catch against first through-slot526 a, thereby ensuring that first proximal anchor 64 a is notprematurely ejected from lumen 523. When ready to deploy the firstproximal anchor, skive rod 540 may be retracted proximal of first motionlimitation through-slot 526 a, thereby freeing the loop of suture formedby knot K_(1A) from the skive rod. First proximal anchor 64 a may thenbe deployed by further distal advancement of the anchor pushrod againstsecond anchor assembly 60 b. The second anchor assembly advances firstproximal anchor 64 a out of needle 522.

First anchor assembly 60 a then may be unidirectionally adjusted asdescribed hereinabove, using first skive 528 a, the loop of sutureformed by first adjustment knot K_(1B) and delivery tube 510. Onceadjusted, skive rod 540 may be further retracted within skive bore 524to a position proximal of first skive 528 a, thereby releasing firstanchor assembly 60 a from anchor delivery system 500. Second anchorassembly 60 b may then be deployed and adjusted in a similar mannerusing second through-slot 526 b, second skive 528 b and second knotsK_(2A) and K_(2B).

As will be apparent to those of skill in the art, although anchordelivery system 500 illustratively has been described in a configurationsuited for delivery of only two anchor assemblies, any number of anchorassemblies may be accommodated, for example, by adding additional pairsof motion limitation through-slots and unidirectional adjustment skivesto needle tube 520. Additionally, spacers, for example, digestiblespacers, wax spacers, polymer spacers, etc., may be provided betweenanchors and/or between anchor assemblies to reduce a risk of prematuredeployment of an anchor or assembly. Additional spacing and motionlimitation techniques will be apparent.

Referring now to FIG. 26, an alternative embodiment of anchor deliverysystem 500 is described. For the purposes of illustration, flexibledelivery tube 510 has been omitted from system 500′ of FIG. 26. However,it should be understood that anchor delivery system 500′ preferablycomprises flexible delivery tube 510.

Anchor delivery system 500′ is substantially the same as system 500,except that first and second through-slots 526 a′ and 526 b′ do notcommunicate with skive bore 524. Rather, through-slots 526′ provideopenings between anchor lumen 523 and the exterior of needle tube 520.Additionally, needle tube 520 further comprises first and second motionlimitation skives 527 a and 527 b, which constrain the loops of sutureformed by first and second motion limitation knots K_(1A) and K_(2A),respectively. It is expected that anchor delivery system 500′ will beeasier to manufacture than system 500. Additionally, enhanced suturemanagement is expected, since a substantial length of first suture 39 aand second suture 39 b is disposed outside of needle tube 520 withinlumen 511 of delivery tube 510 (see FIG. 25) during delivery. As withanchor delivery system 500, delivery system 500′ may be provided withspacers between anchors and/or anchor assemblies to reduce a risk ofpremature anchor deployment.

Anchor delivery systems 500 and 500′ of FIGS. 25 and 26, respectively,provide for delivery and deployment of multiple adjustable anchorassemblies from a linear stack of anchors disposed within a lumen of theneedle tube. FIG. 27 illustrate a first embodiment of an alternativeanchor delivery system wherein the multiple anchor assemblies aredelivered and deployed from chambers of a radial stack or revolverdisposed about the needle tube, without necessitating reloading orremoval from the patient. Either the revolver or the needle tube (orboth) may be rotated to align the needle tube with successive chambersof the revolver for reloading the needle tube with anchor assembliesfrom the radial stack.

In FIG. 27, anchor delivery system 600 comprises flexible delivery tube610, flexible needle tube 620, anchor pushrod 630 and revolver 640.Flexible delivery tube 610 comprises lumen 612. Needle tube 620comprises needle 622, anchor loading slot 624, anchor lumen 626 andplurality of adjustment skives 628. Skives 628 are disposed over alongitudinal length of needle tube 620 and optionally may be disposed atvarying radial positions about needle tube 620. Anchor pushrod 630 istranslatably disposed within anchor lumen 626 of needle tube 620 fordeployment and adjustment of anchor assemblies 60, and both needle 622and anchor slot 624 communicate with lumen 626. Revolver 640, comprisingplurality of chambers 642, preferably is coupled to, or is integralwith, flexible delivery tube 610. Chambers 642 communicate with lumen612 of flexible delivery tube 610.

Chambers 642 preferably are pre-loaded with plurality of anchorassemblies 60. Furthermore, lumen 626 of needle tube 620 preferably ispre-loaded with first anchor assembly 60 a. Sutures 39 extend proximallyfrom anchor assemblies 60 to skives 628, where sutures 39 form knottedsuture loops K that are reversibly constrained within lumen 626 ofneedle tube 620 by anchor pushrod 630, in order to facilitate adjustmentof the length of suture disposed between the proximal and distal anchorsof each assembly, as discussed previously.

Suture 39 a of first anchor assembly 60 a extends proximally from firstproximal anchor 64 a through anchor loading slot 624 to first skive 628a, where it forms first knotted suture loop K_(a). In use, anchorpushrod 630 may be used to deploy first anchor assembly 60 a from lumen626 of needle tube 620, for example, with distal anchor 62 a disposed onthe distal side of a tissue fold and proximal anchor 64 a disposed onthe proximal side. After adjustment in the manner described previously,anchor pushrod 630 may be retracted proximally to a position proximal offirst skive 628 a, thereby freeing first knotted suture loop from lumen626. Proximal retraction of anchor delivery system 600 with respect tofirst anchor assembly 60 a completely removes suture 39 a from thedelivery system, thereby completing deployment of first anchor assembly60 a.

As discussed previously, chambers 642 of revolver 640 communicate withlumen 612 of flexible delivery tube 610. This facilitates loading ofsuccessive anchor assemblies 60 within needle tube 620 by longitudinallyand radially aligning successive loaded chambers 642 of revolver 640with anchor loading slot 624 of the needle tube. Needle tube 620 andrevolver 640 optionally may be initially aligned such that second anchorassembly 60 b disposed in chamber 642 b drops through anchor loadingslot 624 into lumen 626 of anchor tube 620 upon retraction of anchorpushrod 630 proximal of anchor loading slot 624, e.g., while releasingfirst knotted suture loop K_(a) from lumen 626. Subsequent loading ofanchor assembly 60 c, etc., post-deployment, -adjustment and -release ofanchor assembly 60 b, may be achieved by rotating needle tube 520 withrespect to revolver 540/delivery tube 510, or vice versa.

In this manner, plurality of anchor assemblies 60 may be delivered anddeployed without necessitating reloading or removal of anchor deliverysystem 600 from the patient. In FIG. 27, revolver 640 illustratively isshown with three loaded chambers 642. However, any alternative number ofchambers and anchor assemblies may be provided, as will be apparent tothose of skill in the art. Additionally, optional motion limitationapparatus may be provided. Furthermore, detents, color-coding or othermechanisms may be provided to facilitate proper radial and longitudinalalignment of delivery tube 610, needle tube 620 (as well as anchorloading slot 624 and skives 628 of the needle tube), anchor pushrod 630and revolver 640 (as well as successive chambers 642 of the revolver)relative to one another.

With reference now to FIGS. 28-34, additional plication apparatus forforming tissue folds is described. FIG. 28 illustrates an alternativeembodiment of apparatus 200 of FIG. 20. Apparatus 200′ is adapted tosimultaneously or sequentially form and approximate a plurality oftissue folds F within tissue wall W. Apparatus 200′ may be used inconjunction with any of the anchors and anchor delivery systemsdescribed hereinabove, as well as with any applicable alternativeanchors or systems, to secure the approximated tissue folds together. Itis expected that approximating and securing a plurality of tissue foldswill have substantial utility in performing a variety of medicaltreatments including, for example, gastric reduction.

In FIG. 28, apparatus 200′ comprises a plurality of articulate-able,flexible tubes 177′, each with a tissue grabbing assembly 18′. Tubes177′ preferably are biased such that the tubes flare outward distal ofsheath 650, thereby ensuring that the portions of tissue wall W plicatedto form tissue folds F are separated by an appropriate distance prior toapproximation, and that the tubes resiliently return to their flaredposition post-plication and release of tissue wall W. Tubes 177′preferably may be translated relative to sheath 650. As seen in FIG.28B, flexible tubes 177′ articulate inward toward a longitudinal axis ofapparatus 200′ in order to form and approximate tissue folds F. As willbe apparent to those of skill in the art, a magnitude of the outwardbias applied to tubes 177′ may be specified such that an appropriateinitial separation distance L between the tissue grasping assemblies fora desired medical treatment is achieved. Furthermore, in order to reducea delivery profile of apparatus 200′, flexible tubes 177′ may bedisposed within sheath 650 (or another external sheath) during delivery.

With reference to FIG. 29, an alternative embodiment of apparatus 10 ofFIG. 1 is described comprising backside stabilization. All plicationapparatus described hereinabove comprise a distal region including atissue grabbing assembly adapted to engage and stretch a portion of atissue wall within a GI lumen at a first tissue contact point. A secondtissue contact point then is established with the tissue wall at alocation initially proximal of, or in line with, the first tissuecontact point. The tissue engaged by the tissue grabbing assembly thenis moved to a position proximal of the second tissue contact point toform a tissue fold, and an anchor assembly may be delivered across thetissue fold, e.g. across the muscularis and serosa layers of the tissuewall.

Apparatus 10′ of FIG. 29 is a first embodiment of apparatus adapted toestablish a third tissue contact point at another location initiallyproximal of, or in line with, the first tissue contact point; additionalembodiments will be described hereinbelow. Upon movement of the tissueengaged by the tissue grabbing assembly to a position proximal of boththe second and third tissue contact points, a tissue fold is formed withthe second and third contact points on opposing sides of the fold. Thesecond and third contact points provide both front and backsidestabilization, respectively, of the tissue fold. When delivering anoptional anchor assembly across the tissue fold from a vicinity of thesecond tissue contact point, backside stabilization at the third tissuecontact point reduces backside tenting of tissue, thereby facilitatinganchor delivery.

In FIG. 29, apparatus 10′ of the present invention comprises torqueablecatheter 11′, which may be configured, for example, for insertionthrough a patient's mouth and esophagus into the patient'sgastrointestinal lumen. Catheter 11′ comprises distal region 12′ havingfirst and second interconnected flexible tubes 13 and 14 extendingtherefrom. Tubes 13 and 14 are joined by hinge assembly 20, and tissuegrabbing assembly 18 is disposed on the distal end of flexible tube 13.The tissue grabbing assembly is coupled to a control wire (not shown)that extends through tube 13 to a proximal region of catheter 11′ (notshown).

Distal region 12′ of apparatus 10′ is substantially the same as distalregion 12 of apparatus 10 of FIG. 1, except that distal region 12′further comprises selectively deployable backside stabilizer 700.Backside stabilizer 700 comprises wire loop 710, which preferably isfabricated from a loop of shape memory material, e.g. Nitinol, coupledto control wire 720 that extends from wire tube 730. the proximal regionof catheter 11′ comprises actuators (not shown) in communication withthe tissue grabbing assembly control wire and control wire 720 foractuating the tissue grabbing assembly and the backside stabilizer,respectively.

Referring to FIGS. 30A-30E, a method of using apparatus 10′ of FIG. 29to form a backside stabilized tissue fold is described. In FIG. 30A,apparatus 10′ is delivered to a treatment site through delivery sheath740 with wire loop 710 compressed to a reduced delivery configurationwithin the delivery sheath. In FIG. 30B, distal region 12′ of catheter11′ is advanced distal of delivery sheath 740, such that wire loop 710expands to a free-space configuration. In FIG. 30C, control wire 720 ofbackside stabilizer 700 is retracted proximally to retract wire loop 710to an intermediate ready position. In FIG. 30D, tissue fold F is formedat tissue wall W with distal region 12′, e.g., as described hereinabovewith respect to FIG. 3.

In FIG. 30E, tension is released from control wire 720, and wire loop710 resiliently moves back towards its free-space configuration. Wireloop 710 of backside stabilizer 700 establishes a third tissue contactpoint on the backside of tissue fold F, thereby providing backsidestabilization to the tissue fold. It is expected that backsidestabilization/ establishment of an opposing third tissue contact pointwill simplify delivery of an anchor assembly across the tissue foldwhile facilitating formation and securing of a serosa-to-serosa fold.

As will be apparent to those of skill in the art, the size, length ordiameter of wire loop 710 may be adjustable to facilitate backsidestabilization of tissue folds of variable size. Furthermore, wire loop710 may be provided as a substantially stagnant loop, i.e. the loop maynot be retractable via control wire 720. In such a configuration, wireloop 710 would apply pressure to the tissue fold as it is formed,thereby facilitating formation of the fold in addition to providingstabilization.

With reference now to FIG. 31, further alternative tissue foldingapparatus comprising optional backside stabilization is described.Apparatus 800 is adapted to linearly retract tissue at tissue wall W inorder to form tissue fold F. The apparatus comprises catheter 810 havingtissue grabbing assembly 18; such as described hereinabove andcomprising a pair of jaws 28 a, 28 b having sharpened teeth 33 arrangedto rotate about pivot point 29 between an open configuration and aclosed configuration; coupled to tube 820 having slot 822. Control wire19 is disposed within the lumen of tube 820 and extends from tissuegrabbing assembly 18 to a proximal end of apparatus 800 (not shown) foractuating the tissue grabbing assembly. Tissue grabbing assembly 18 isconfigured to establish a first tissue contact point with tissue wall Wand may be retracted proximally via tube 820 to facilitate formation oftissue fold F.

Apparatus 800 further comprises frontside and backside linkages 830 aand 830 b, respectively. Proximal regions of the linkages are pivotablyand translatably disposed within slot 822 of tube 820. A distal regionof frontside linkage 830 a is pivotably coupled to anchor delivery tube840 for delivery of an anchor assembly across a tissue fold, asdescribed previously, while a distal region of backside linkage 830 b ispivotably coupled to backside stabilizer 850. Anchor delivery tube 840and backside stabilizer 850 preferably are biased such that theysubstantially align with the longitudinal axis of apparatus 800 when notunder stress. Such alignment may be achieved, for example, by formingthe elements from spring tube, or by providing the elements withresilient spines, e.g. Nitinol spines. Tube 840 and stabilizer 850 areconfigured to establish second and third tissue contact points,respectively, at tissue wall W, thereby providing frontside and backsidestabilization of a tissue fold formed at the wall, as describedhereinabove.

Referring again to FIG. 31, a method of using apparatus 800 to formtissue fold F at tissue wall W is described. In FIG. 31A, tissuegrabbing assembly 18 has been advanced to a vicinity of tissue wall Wwith the proximal ends of linkages 830 disposed near the proximal end ofslot 822 in tube 820. Tissue grabbing assembly 18 is then actuated viaretraction of control wire 19 to grab tissue and establish the firsttissue contact point. With tissue engaged, continued retraction ofcontrol wire 19 causes proximal retraction of tube 820 and assembly 18in a substantially linear fashion relative to linkages 830, as seen inFIG. 31B.

As tube 820 is linearly retracted, linkages 830 slidably translatewithin slot 822 of the tube 820 until the proximal regions of thelinkages contact a distal end of slot 822. As seen in FIG. 31C, furtherproximal retraction of tube 820 beyond this bottoming-out point of slot822 causes linkages 830 to rotatably pivot at both their proximal anddistal regions. This, in turn, causes anchor delivery tube 840 andbackside stabilizer 850 to rotate inwards and form the second and thirdtissue contact points, respectively, thereby forming frontside andbackside-stabilized tissue fold F. Upon re-advancement of tube 820,anchor delivery tube 840 and backside stabilizer 850 resiliently realignwith the longitudinal axis of apparatus 800.

Previous plication apparatus described hereinabove require more complexmotion than linear retraction on the part of the tissue grabbingassembly in order to form tissue fold F. It is expected that reducingmovement of the tissue grabbing assembly during tissue folding to alinear motion will reduce a magnitude of working space required at atreatment site to achieve formation of the tissue fold. As will beapparent to those of skill in the art, as an alternative to linearlyretracting tube 820 relative to linkages 830 in order to form tissuefold F, linkages 830 may be linearly advanced relative to tube 820.Also, backside linkage 830 b and backside stabilizer 850 (as well asconcomitant backside stabilization of tissue fold F) optionally may beomitted. Alternatively, backside stabilizer 850 may comprise a secondanchor delivery tube, e.g., for delivery of an anchor assembly acrosstissue fold F from the backside, for passage of all or part of an anchorassembly from frontside anchor delivery tube 840 to the backsidestabilizer across the tissue fold, or for delivery of a multiplecomponent anchor assembly having a first component deployable from thefrontside anchor delivery tube and a second component deployable via thebackside stabilizer. The first and second components optionally may becoupled together to form a composite anchor assembly. Additionalconfigurations will be apparent to those of skill in the art.

Furthermore, slot 822 optionally may be omitted from tube 820, and thetube alternatively may be provided with proximal and distal stopsdisposed on the exterior of, or formed integral with, the tube near itsdistal end. In this arrangement, the proximal ends of linkages 830 wouldbe pivotably and translatably disposed about the exterior of tube 820,such that the proximal and distal stops limit translation of thelinkages relative to the tube. In both this arrangement and thearrangement of FIG. 31, tube 820 acts as a linear bearing about whichlinkages 830 may travel.

With reference now to FIG. 32, an alternative embodiment of apparatus800 of FIG. 31 is described. Apparatus 800′ is substantially the same asapparatus 800, except that linkages 830 have been replaced with controlwires 830′, while slot 822 of tube 820 has been replaced with skive 822′of tube 820′. Additionally, anchor delivery tube 840′ and backsidestabilizer 850′ comprise optional pulley eyelets 860 a and 860 b,respectively, for routing of control wires 830′. Control wires 830′ areproximally coupled to control wire 19 of tissue grabbing assembly 18within the lumen of tube 820′. Control wires 830′ exit the lumen atskive 822′ and extend distally through optional pulley eyelets 860.Control wire 830 a′ is distally coupled to anchor delivery tube 840′,while control wire 830 b′ is distally coupled to backside stabilizer850′.

A length of control wires 830′ is specified such that retraction ofcontrol wire 19 causes actuation of tissue grabbing assembly 18 andretraction of tube 820′, prior to control wires 830′ being pulled taut.Once control wires 830′ have been pulled taut, continued retraction ofcontrol wire 19 causes control wires 830′ to reversibly rotate anchordelivery tube 840′ and backside stabilizer 850′ inward, thereby formingthe second and third tissue contact points and forming frontside- andbackside-stabilized tissue fold F at tissue wall W. As with apparatus800, backside stabilizer 850′ (as well as associated control wire 830b′) of apparatus 800′ optionally may be omitted.

Referring to FIG. 33 further alternative tissue folding apparatuscomprising optional backside stabilization is described. Apparatus 900comprises outer tube 910 having distal region 912 with rigid orresilient frontside and backside stabilizers 914 a and 914 b,respectively. When substantially rigid, stabilizers 914 may be formed,for example, from a shaped stainless steel wire or rod. When resilient,the stabilizers may be formed, for example, from a wire or rod of shapememory material such as Nitinol or from a thinner wire or rod ofstainless steel. The durometer of the material used to fabricatestabilizers 914 may be specified to achieve a desired degree of rigidityor resiliency.

Apparatus 900 further comprises inner tube 920, which is coaxially andslidably disposed within outer tube 910. Tissue grabbing assembly 922,coupled to a distal region of inner tube 910, comprises helical coil 924having sharpened distal tip 925. Helical coil 924 is adapted toreversibly engage tissue by reversibly screwing the coil into the tissuein a manner similar to a wine corkscrew, and as demonstrated by arrowsin FIG. 33A. As will be apparent to those of skill in the art, as analternative or adjunct to helical coil 924, tissue grabbing assembly 922may comprise a jaw structure similar to that of assembly 18; likewiseany of the previously described tissue folding apparatus optionally maycomprise a tissue grabbing assembly having a helical coil. Additionaltissue grabbing assemblies, per se known, will be apparent in view ofthis disclosure.

FIG. 33 illustrate a method of forming a tissue fold with apparatus 900.In FIG. 33A, tissue grabbing assembly 922 is advanced distal ofstabilizers 914 to engage tissue at tissue wall W at a first tissuecontact point. Helical coil 924 is screwed into the tissue, and innertube 920 is then retracted relative to outer tube 910, and/or the outertube is advanced relative to the inner tube, such that tissue engaged byassembly 922 is pulled proximal of stabilizers 914, as seen in FIG. 9B.Stabilizers 914 contact the tissue at second and third contact points,and form frontside- and backside-stabilized tissue fold F. When rigid, across-sectional width of tissue fold F may be specified by a separationdistance between the frontside and backside stabilizers. When resilient,the stabilizers may bow outward to facilitate formation of the tissuefold by decreasing a pulling force required by coil 924 to form thefold, as well as by reducing a risk of the coil detaching from, ortearing through, the tissue during fold formation.

As will be apparent to those of skill in the art, one of stabilizer 914a and stabilizer 914 b optionally may be omitted when only a secondtissue contact point is required. Additionally, apparatus 900 may beused in conjunction with an anchor delivery system, such as thosedescribed previously; the anchor delivery system optionally may providethe third tissue contact point. Also, one or both of stabilizers 914 maybe extendable/retractable relative to distal region 912 of outer tube910 of apparatus 900. Likewise, the stabilizers may be sizable in vivoto facilitate formation of a tissue fold of specified magnitude.

With reference now to FIG. 34, another embodiment of plication apparatuscomprising backside stabilization is described. In contrast topreviously described apparatus, apparatus 950 achieves backsidestabilization of a tissue fold via tissue contact over an arcuatesegment, as opposed to at discrete points or along a line. In FIG. 34,full 360° radial contact around the fold is established; however, aswill be apparent to those of skill in the art, contact alternatively maybe established at one or more locations over one or more arcuatesegments of less than 360°.

Apparatus 950 comprises inner tube 960 and coaxially disposed outer tube970. Inner tube 960 comprises tissue grabbing assembly 18 coupled to adistal of the tube. Apparatus 950 further comprises braided mesh 980having proximal end 982 coupled to a distal end of outer tube 970, anddistal end 984 coupled to inner tube 960 proximal of tissue grabbingassembly 18. Braided mesh 980 preferably is fabricated from polymer ormetal wires. Upon advancement of outer tube 970 relative to inner tube960, the mesh may be everted, e.g. over a tissue fold, to providefrontside and backside stabilization of a fold via arcuate contact. Aswill be apparent, apparatus 950 may be used in conjunction with ananchor delivery system to secure a stabilized tissue fold.

FIG. 34 illustrate a method of using apparatus 950 to form a stabilizedtissue fold. In FIG. 34A, tissue grabbing assembly 18 engages tissuewall W at a first tissue contact point. In FIG. 34B, with tissue engagedby assembly 18, inner tube 960 is retracted relative to outer tube 970and/or outer tube 970 is advanced relative to inner tube 980, such thatproximal end 982 is advanced distal of distal end 984 of braided mesh980. The braided mesh everts about tissue fold F, thereby providingfrontside and backside stabilization to the tissue fold via contact overa full 360° radial segment (braided mesh 980 shown in section in FIG.34B).

FIGS. 29-34 have illustrated exemplary plication apparatus comprisingoptional elements for backside stabilizing tissue folds formed with theapparatus. As will be apparent to those of skill in the art, backsidestabilization elements optionally may also be provided with any otherplication apparatus of the present invention. Furthermore, backsidestabilization elements may be provided with any anchor delivery system,e.g., in order to reduce tissue tenting during deployment of an anchorassembly across a tissue fold.

With reference now to FIGS. 35-39, an embodiment of a shape-lockableguide for use with tools of the present invention is described.Shape-lockable guides have been described previously in Applicant'sco-pending U.S. patent application Ser. No. 10/173,203, filed Jun. 13,2002, which is incorporated herein by reference in its entirety and fromwhich the present invention claims priority. As discussed hereinabove, asignificant indication for use of the tissue grabbing assemblies,plication apparatus, anchor delivery systems and anchor assemblies ofthe present invention is within a patient's gastrointestinal (“GI”)lumen. However, the GI lumen varies significantly in geometry andmaterial properties along its length, and it is expected that properlypositioning, as well as visualizing, endoluminal tools of the presentinvention at any desired location within the GI lumen will presentsignificant challenges. Transmitting forces and torques to the toolsover substantial separation distances between a medical practitioner andthe working ends of the tools within the GI lumen presents additionalchallenges. It therefore would be nice to provide guide apparatuscapable of providing exposure or targeting, stability, and flexibilityto tools of the present invention when disposed within a patient.

Apparatus 1000 of FIGS. 35-39 addresses these challenges by facilitatingplacement of a diagnostic instrument, such as an endoscope, e.g., acolonoscope or gastroscope; and/or a therapeutic instrument, such asthose described hereinabove; through the tortuous or unpredictablysupported anatomy of a hollow body organ, such as the colon, esophagusand/or stomach; while reducing a risk of distending or injuring theorgan. Apparatus 1000 permits such instruments to be readily advancedinto the patient's tortuous or unpredictably supported anatomy byselectively shape-fixing an overtube portion of the apparatus, whilealso preventing tissue from being captured or pinched between theovertube and the instrument(s). Although apparatus 1000 illustrativelycomprises an overtube, it should be understood that apparatus 1000alternatively may comprise a selectively rigidizable, shape-fixing orshape-locking guide wire or inner conduit, over which diagnostic ortherapeutic instruments may be advanced.

Referring now to FIG. 35, apparatus 1000 of the present invention isdescribed. Apparatus 1000 comprises handle 1001, overtube 1002, anddistal region 1003 having atraumatic tip 1004. Handle 1001 includeslumen 1005 that extends from Toughy-Borst valve 1006 through overtube1002, distal region 1003 and atraumatic tip 1004. Lumen 1005 isconfigured to facilitate passage of a standard commercially availableendoscope, such as endoscope 1100 having steerable distal tip 1101 (seeFIG. 40), and/or a therapeutic device of the present invention, e.g. atissue grabbing assembly, plication apparatus, an anchor deliverysystem, or an anchor assembly, therethrough. Although apparatus 1000illustratively comprises a single lumen, multiple lumens optionally maybe provided for passage of multiple diagnostic and/or therapeuticinstruments. Toughy-Borst valve 1006 may be actuated to releasably lockinstrument(s) to apparatus 1000 when the instrument(s) are insertedwithin lumen 1005. As described hereinafter, overtube 1002 is configuredso that it can be selectively transitioned between a flexible state anda rigid, shape-fixed state by actuator 1007 disposed on handle 1001.

In FIG. 36, an illustrative embodiment of overtube 1002 comprises amultiplicity of nestable elements 1010. For purposes of illustration,nestable elements 1010 are shown spaced-apart, but it should beunderstood that elements 1010 are disposed so that their adjacentsurfaces 1011 and 1012 coact. Each of nestable elements 1010 has centralbore 1013 to accommodate diagnostic and therapeutic instruments, andpreferably three or more tension wire bores 1015. When assembled asshown in FIG. 35, nestable elements 1010 are fastened with adjacentsurfaces 1011 and 1012 disposed in a coacting fashion by a plurality oftension wires 1016 that extend through tension wire bores 1015.

In a preferred embodiment, adjacent surfaces 1011 and 1012 of eachnestable element 1010 are contoured to mate with the next adjacentelement, so that when tension wires 1016 are relaxed, surfaces 1011 and1012 can rotate relative to one another. Tension wires 1016 are fixedlyconnected to the distal end of overtube 1002 at their distal ends and toa tensioning mechanism disposed within handle 1001 at their proximalends. When actuated by actuator 1007, tension wires 1016 impose a loadthat clamps adjacent surfaces 1011 and 1012 of nestable elements 1010together at the current relative orientation, thereby fixing the shapeof overtube 1002.

When the load in tension wires 1016 is released, tension wires 1016provide for relative angular movement between nestable elements 1010.This in turn renders overtube 1002 sufficiently flexible to negotiate atortuous path or unpredictably supported anatomy through, for example,any region of a patient's GI lumen, such as the colon, esophagus and/orstomach. When the tensioning mechanism is actuated, however, tensionwires 1016 are retracted proximally to apply a clamping load to thenestable elements. This load prevents further relative movement betweenadjacent elements 1010 and stiffens overtube 1002, so that any distallydirected force applied to instruments within lumen 1005 causes theworking ends of the instruments to advance further into the GI lumen,rather than cause overtube 1002 to bear against the wall of the lumen orlose its spatial orientation within an unpredictably supported space.The shape-fixed overtube absorbs and distributes vector forces,shielding the GI lumen.

Referring now to FIG. 37, an illustrative embodiment of distal region1003 and atraumatic tip 1004 is described. Distal region 1003 comprisesflexible, kink-resistant coil 1021 encapsulated in flexible layer 1022.Layer 1022 preferably comprises a soft elastomeric and hydrophiliccoated material, such as silicon or synthetic rubber, and extendsthrough bores 1013 of nestable elements 1010 to form liner 1023 forlumen 1005. Layer 1022 extends to handle 1001 at the proximal end, andat the distal end terminates in enlarged section 1024 that formsatraumatic tip 1004.

Layer 1022 preferably joins with or is integrally formed with flexibleelastomeric cover 1025 which encapsulates nestable elements 1010 inannular chamber 1026. Cover 1025 provides a relatively smooth outersurface for overtube 1002, and prevents tissue from being captured orpinched during relative rotation of adjacent nestable elements 1010.

In accordance with one aspect of the present invention, endoscope 1100may be positioned with its distal tip 1101 disposed in distal region1003, so that deflection of steerable distal tip 1101 imparts an angulardeflection to distal region 1003 and atraumatic tip 1004. To ensure thatthere is no gross relative motion between endoscope 1100 or otherinstruments within lumen 1005 and apparatus 1000, Toughy-Borst valve1006 is tightened to engage apparatus 1000 to the endoscope/instruments.In this manner, the instrument(s) and distal region 1003 may besimultaneously advanced through the colon, with the distal tip ofendoscope 1100 providing a steering capability to apparatus 1000.Apparatus 1000 therefore may be advantageously advanced together withinstruments disposed within lumen 1005 when overtube 1002 is in theflexible state, reducing relative motion between apparatus 1000 and suchinstruments to those instances where overtube 1002 must be shape-lockedto prevent distension or to maintain distal region 1003 orientation withthe GI lumen.

Still referring to FIG. 37, terminations 1027 of tension wires aredescribed. Terminations 1027 illustratively comprise balls welded ormolded onto the ends of tension wires 1016 that ensure the tension wirescannot be pulled through tension wire bores 1015 of the distalmostnestable element 1010. This ensures that the nestable elements cannotcome loose when overtube 1002 is disposed within a patient.

Alternatively, terminations 1027 may comprise knots formed in the endsof tension wires 1016, or any suitable fastener that prevents thetension wires from being drawn through the tension wire bores of thedistal-most nestable element. Advantageously, cover 1025 providesadditional assurance that all of nestable elements 1010 can be safelyretrieved from a patient's colon in the unlikely event of a tension wirefailure.

Referring now to FIGS. 35 and 38, tension wires 1016 within overtube1002, liner 1023 and lumen 1005 extend from distal region 1003, throughovertube 1002, and to handle 1001. Within handle 1001, each tension wire1016 passes through wire lock release 1031 fixedly attached to handle1001, and wire lock 1032 disposed on slide block 1033. Each tension wire1016 terminates at wire tension spring 1034, which maintains tensionwires 1016 in light tension even when overtube 1002 is in the flexiblestate. The degree of tension provided by wire tension springs 1034 isnot sufficient to clamp adjacent nestable elements 1010 together, but onthe other hand does not let gaps form between adjacent nestableelements, and helps to manage the tension wire take up or slack asovertube 1002 makes various bends.

Slide block 1033 is keyed to slide along rail 1035 disposed betweenlimit blocks 1036 and 1037, and comprises a rigid block having a borethrough which rail 1035 extends and an additional number of bores asrequired for the number of tension wires 1016 employed. Rack gear 1038is fixedly coupled to side block 1033. Rack 1038 mates with pinion gear1039, which is in turn driven by bidirectional pawl 1040 coupled toactuator 1007. Pinion gear 1039 may be selectively engaged by eitherprong 1041 or 1042 of bidirectional pawl 1040, depending upon theposition of selector switch 1043.

If prong 1041 is selected to be engaged with pinion gear 1039, asqueezing action applied to actuator 1007, illustratively hand grip1044, causes rack 1033 to move in the D direction in FIG. 38, therebyapplying tension to tension wires 1016. Repeated actuation of hand grip1044 causes slide block 1033 to move progressively further in directionD, thereby applying an increasing clamping load on nestable elements1010. Any slack lengths of tension wires 1016 extending below slideblock 1033 are taken up by wire tension springs 1034. As discussed ingreater detail below with respect to FIG. 39, wire locks 1032, which areaffixed to slide block 1033, engage and retract tension wires 1016concurrently with movement of slide block 1033 in the D direction.

If prong 1042 is instead chosen by selector switch 1043 to engage piniongear 1039, repeated actuation of hand grip 1044 causes slide block 1033to translate in direction U, thereby relaxing the tensile load appliedby tension wires 1016 to nestable elements 1010. Repeated actuation ofhand grip 1044 causes slide block 1033 to advance in direction U untilwire lock releases 1031 engage wire locks 1032, releasing all tensionfrom tension wires 1016 except that provided by wire tension springs1034. This action permits the clamping forces imposed on nestableelements 1010 to be progressively reduced and render overtube 1002progressively move flexible, until when wire lock releases 1031 engagewire locks 1032, the overtube is returned to its most flexible state.

Referring to FIG. 39, wire lock 1032 and lock release 1031 are describedin greater detail. Wire lock 1032 includes jaws 1045 disposed withincollet 1046. Collet 1046 includes a tapered conical bore 1047. Jaws 1045have ramped exterior surfaces 1048 and teeth 1049, and are biasedagainst the surface formed by the tapered conical bore by springs 70.Teeth 1049 are configured to engage tension wire 1016 under the biasforce of springs 70. When slide block 1033 is moved in direction D (seeFIG. 38), jaws 1045 engage and grasp tension wire 1016 and retract thetension wire in direction D.

To disengage teeth 1049 from tension wire 1016, e.g., when it is desiredto allow overtube 1002 to return to a flexible state, slide block 1033is actuated as described previously to move in direction U. Furtheractuation of slide block 1033 towards limit block 1036 and wire lockrelease 1031 causes wire lock release 1031 to extend into taperedconical bore 1047 and push jaws 1045 backward against the bias ofsprings 70. Once tension wires 1016 are freed from jaws 1045, overtube1002 returns to its most flexible state.

In FIGS. 35-39, apparatus 1000 has been described as having a flexiblestate and rigid state. However, it should be understood that apparatus1000 optionally may comprise one or more intermediary states whereinovertube 1002 is only partially flexible or only partially rigid.Furthermore, overtube 1002 optionally may comprise one or more sectionsof varied rigidity or flexibility in either the flexible or the rigidstate, or both, as compared to one or more other sections of theovertube. For example, at least one section of the overtube may remainin the flexible state upon transition of the overtube to the rigidstate. Alternatively, at least one section of the overtube may comprisevaried rigidity relative to a different section of the overtube when theovertube is disposed in the rigid state. As yet another alternative, atleast one section of the overtube may comprise varied flexibilityrelative to a different section of the overtube when the overtube isdisposed in the flexible state. Additional configurations will beapparent to those of skill in the art.

It should be understood that apparatus 1000 optionally may be providedwith steering capabilities in addition to locking capabilities, in orderto properly position apparatus 1000 within a GI lumen, e.g. prior tolocking the overtube in a desired orientation. Such steeringcapabilities may be achieved, for example, using tensioning orstiffening wires, per se known. Additional steering techniques will beapparent to those of skill in the art.

As an alternative, or in addition, to advancing diagnostic and/ortherapeutic instruments through one or more lumens of apparatus 1000,such instruments optionally may be coupled to apparatus 1000. Forexample, an endoscope, a tissue grabbing assembly, plication apparatusand/or an anchor delivery system in accordance with the presentinvention, may be coupled to distal region 1003 of apparatus 1000.Alternatively, such instruments may be telescopically disposed andadvanced from within distal region 1003. Coupling instruments or toolsto a shape-lockable guide is described in more detail, for example, inApplicant's co-pending U.S. patent application Ser. No. 10/458,060,filed Jun. 9, 2003, which is incorporated herein by reference in itsentirety and from which the present invention claims priority.Additional configurations will be apparent to those of skill in the art.

With reference now to FIG. 40, in conjunction with FIG. 41, a method ofperforming endoluminal gastric reduction is described utilizing a systemof tools illustratively comprising commercially available gastroscope1100, plication apparatus 10 of FIGS. 1-3, anchor delivery system 250 ofFIG. 21 loaded with anchor assembly 60 of FIG. 7, and shape-lockableapparatus 1000 of FIGS. 35-39. Gastric reduction is a technique forreducing a patient's appetite and/or ability to ingest food by reducinga volume of the stomach through which food may pass. Endoluminal gastricreduction in accordance with the present invention entails partitioningthe stomach into first and second chambers, and more specifically into asmall lumen or pouch and a larger chamber, over at least a portion ofthe stomach.

The lumen/pouch preferably has a volume of approximately 10-50 cm³, andeven more preferably a volume of approximately 15 cm³, and is positionednear and inferior to the patient's gastroesophageal junction. Ingestedfood may only pass through the small lumen over the partitioned portionof the stomach. The lumen preferably is formed by approximating opposinganterior and posterior segments of the patient's stomach wall over alength or arc of the wall near and inferior to the gastroesophagealjunction.

As illustrated in FIGS. 40 and 41, endoscopic gastric reduction may beachieved by endoscopically forming, approximating and securing aplurality of tissue folds in a first plane within a patient's stomach,then endoscopically forming, approximating and securing at least oneadditional plurality of tissue folds in at least one substantiallyparallel plane within the patient's stomach. The first plurality oftissue folds and the at least one additional plurality of tissue foldsmay be attached or detached from one another. Each plurality of foldspreferably comprises one or more tissue folds from opposing anterior andposterior segments of the stomach near and inferior to thegastroesophageal junction.

More, specifically, endoscopic gastric reduction may be achieved byadvancing an overtube through a patient's esophagus into the patient'sstomach while the overtube is disposed in a flexible state, thentransitioning the overtube to a rigid state in a desired orientationwithin the patient's stomach. A plication device, either coupled to theovertube or advanced therethrough, may then be used to form theplurality of tissue folds, while an anchor delivery system may be usedto approximate and/or secure the tissue folds, thereby partitioning thepatient's stomach.

In FIG. 40, overtube 1002 of shape-lockable apparatus 1000illustratively comprises first and second lumens 1005 a and 1005 b forpassage of gastroscope 1100 and plication apparatus 10/anchor deliverysystem 250, respectively. In FIG. 40A, optional thin wall sheath 2000 isdisposed within a patient's gastrointestinal lumen through the patient'smouth, into esophagus E, past the gastroesophageal junction GE, and intothe patient's stomach S. Shape-lockable overtube 1002 of apparatus 1000is advanced through sheath 2000 into stomach S while disposed in theflexible state. Sheath 2000 provides a barrier between overtube 1002 andesophagus E, which may facilitate increased maneuverability of apparatus1000 by protecting the esophagus during optional torqueing, translationand/or articulation of overtube 1002.

In FIG. 40A, gastroscope 1100 illustratively has been advanced throughlumen 1005 a of overtube 1002 past distal region 1003 while the overtubeis disposed in the flexible state. As will be apparent to those of skillin the art, a visualization element alternatively or additionally may becoupled to overtube 1002; multiple point visualization may facilitatecomplex procedures and/or enable triangulation for deployment of anchorassemblies across tissue folds. Furthermore, plication apparatus 10 andanchor delivery system 250 optionally may be coupled to the overtube ormay be advanced through the overtube while the tube is disposed in theflexible state.

In FIG. 40B, overtube 1002 is articulated to an orientation wherebydistal region 1003 facilitates engagement of tissue near and inferior tothe patient's gastroesophageal junction GE. Such articulation may beachieved, for example, by actuating steerable distal tip 1101 ofgastroscope 1100. Alternatively, apparatus 1000 may comprise steeringfeatures. As yet another alternative, a steering tool, such as a shapedwire, may be advanced through second lumen 1005 b to properly orient theovertube. Furtherstill, the overtube may comprise a preformed flexibleshape whereby the overtube assumes an arcuate configuration, and a rigidwire may be reversibly disposed with second lumen 1005 b of overtube1002 in order to straighten the overtube during insertion throughesophagus E; upon positioning of distal region 1003 of apparatus 1000within stomach S, the wire may be removed from the lumen, such thatovertube 1002 re-assumes its pre-formed shape. As yet anotheralternative, plication apparatus 10 and/or anchor delivery system 250may comprise steering features and may be advanced through the secondlumen to steer the overtube into position.

With apparatus 1000 disposed in the desired configuration ororientation, the apparatus is reversibly shape-locked to a rigid stateas described previously, such that the apparatus maintains its positionwithin the stomach. Preferably, the articulated portion of apparatus1000 traverses an arc of substantially continuous radius of curvature inthe shape-locked configuration, thereby reducing a magnitude of forcesrequired to advance and retract instruments through overtube 1002. In apreferred embodiment, the arc traverses approximately 270° and has aradius of curvature between about 5 and 10 cm, and, even morepreferably, approximately 7-8 cm. By retroflexing about 270°, distalregion 1003 of apparatus 1000 is directed back towards the body ofovertube 1002 near and inferior to gastroesophageal junction GE.

Plication apparatus 10 and anchor delivery system 250 are advancedthrough second lumen 1005 b of overtube 1002 distal of distal region1003 (alternatively, the plication apparatus and anchor delivery systemmay be coupled to the overtube). As seen in FIG. 40C, e.g. undervisualization provided by gastroscope 1100, tissue is engaged withinstomach S using tissue grabbing assembly 18. Tissue fold F is formed,for example, as described previously with respect to FIG. 3. Anchorassembly 60 then is deployed across the tissue fold via anchor deliverysystem 250 and is adjusted to secure the fold, for example, as describedhereinabove with respect to FIG. 21.

As discussed previously and seen in FIG. 41, in order to achieveendoluminal gastric reduction, opposing anterior An and posterior Posurfaces of stomach S are drawn together to partition the stomach intofirst lumen or pouch P and second larger chamber C. As seen in FIG. 41C,in order to achieve such partitioning, a plurality of folds is formed onthe opposing surfaces in a first plane P₁. The opposing folds areconnected by suture 39 or by other means and are approximated, forexample, by reducing a length of suture disposed between the opposingsurfaces, to partition the stomach as in FIG. 41B.

Optionally, at least one additional plurality of folds may be formed onthe opposing anterior An and posterior Po surfaces in at least oneadditional plane that is substantially parallel to first plane P₁. FIGS.40D and 41C comprise optional additional pluralities of tissue folds insecond and third planes P₂ and P₃. In effect, an anterior ridge AR oftissue folds is formed, and an opposing posterior ridge PR of tissuefolds is formed. These additional pluralities of tissue folds may beattached to the first plurality of tissue folds, as in FIG. 41C, or maybe unattached. Upon approximation of the tissue folds, for example, viacinching of suture 39, pouch P is formed, and endoluminal gastricreduction is achieved.

The number of planes in which pluralities of tissue folds are formed maybe specified based on a preferred longitudinal spacing of anchorassemblies and/or based upon a desired length of pouch P. The desiredlength L may be specified based on a desired volume V of pouch P and adiameter D of pouch P, according to the following equation:L=4V/(πD ²)  (1)For example, overtube 1002 preferably has an outer diameter ofapproximately 1.6 cm. Thus, the diameter of pouch P must be at least 1.6cm, so that the overtube may pass through the pouch. Assuming a pouchdiameter of approximately 1.6 cm, and in order to provide the pouch witha volume of about 15 cm³, a length of pouch P should be about 7.5 cm.

Referring again to FIG. 40C, in order to form, secure and approximatetissue folds on opposing anterior An and posterior Po surfaces ofstomach S, as well as in multiple planes P_(X), overtube 1002 preferablycomprises multiple degrees of freedom. Arrows in FIG. 40C describeillustrative directions in which apparatus 1000 may be maneuvered tore-orient or reconfigure overtube 1002. Specifically, apparatus 1000 maybe translated relative to esophagus E and sheath 2000, as described byarrow Tr. Furthermore, apparatus 1000 may be torqued, as described byarrow To. Furtherstill, the apparatus may be articulated, as describedby arrow ARt. As will be apparent, additional or alternative degrees offreedom optionally may be provided.

As an example, a medical practitioner translating or torqueing handle1001 of apparatus 1000 from external to the patient may achievetranslation and torqueing of overtube 1002. Articulation may be achievedby a number of means, such as steering features provided within overtube1002, e.g. a tensioning wire, or by temporarily returning overtube 1002to the flexible state, actuating steerable end 1101 of gastroscope 1100to articulate overtube 1002 to a desired configuration, then once againshape-locking overtube 1002 to the rigid state. Combinations oftorqueing, translation and articulation may be used to position overtube1002 in any desired configuration.

In FIG. 40D, by repositioning overtube 1002, re-loading anchor deliverysystem 250, and re-actuating plication apparatus 10 and anchor deliverysystem 250, tissue folds have been formed, secured and approximated onopposing surfaces in multiple planes, thereby forming pouch P andchamber C within stomach S. Overtube 1002 has been transitioned back tothe flexible state, and all instruments advanced through the overtubehave been removed from apparatus 1000. Overtube 1002 and optional sheath2000 now may be removed from stomach S and esophagus E through pouch P,thereby completing endoluminal gastric reduction.

With reference now to FIG. 42, a method of treating gastroesophagealreflux disease (“GERD”) using the system of tools described with respectto FIG. 40 is provided. Apparatus 1000 is advanced through a patient'sesophagus E with overtube 1002 disposed in a flexible state. Once again,optional sheath 2000 may be provided between esophagus E and apparatus1000. The apparatus is then manipulated, for example, as describedhereinabove, into a configuration enabling access to tissue in avicinity of the patient's gastroesophageal junction GE. Overtube 1002 isthen shape-locked to a rigid state, as seen in FIG. 42A.

In FIG. 42B, plication apparatus 10 (either advanced through or coupledto apparatus 1000) is used to form tissue fold F₁ on a first side ofgastroesophageal junction GE. Anchor assembly 60, which is deployed andadjusted via anchor delivery system 250, secures the tissue fold.Visualization of the procedure is achieved, for example, via gastroscope1100.

Tissue fold F₁ provides a flap that reduces reflux of acid or otherstomach materials into esophagus E. In patients with more seriousconditions, it may be necessary to provide one or more additional foldsaround gastroesophageal junction GE. For example, apparatus 1000 may berepositioned, anchor delivery system 250 reloaded, and opposing fold F₂formed, as in FIG. 42C. After a desired pressure differential has beenestablished across gastroesophageal junction GE, overtube 1002 may bereturned to the flexible state, and apparatus 1000, as well as anyinstruments advanced therethrough or coupled thereto, may be removedfrom the patient, thereby providing endoluminal treatment ofgastroesophageal reflux disease. Optionally, first and second pressuresensors Pr₁ and Pr₂ may be provided along the length of apparatus 1000to measure the pressure differential across gastroesophageal junctionGE, as seen in FIG. 42B. In use, first pressure sensor Pr₁ may bepositioned distal of the junction within the patient's stomach S, whilesecond pressure sensor Pr₂ is disposed proximal of the junction withinthe patient's esophagus E. Additional or alternative sensors will beapparent to those of skill in the art.

With reference now to FIG. 43, an alternative method for achievingendoluminal gastric reduction or remodeling is described. InamedCorporation of Santa Barbara, Calif., markets the BioEnterics® LAP-BAND®System, which consists of an inflatable silicone band that islaparoscopically placed within a patient's abdomen. The band is fastenedaround the upper stomach, giving the stomach an hourglass profile andcreating a tiny stomach pouch that limits and controls an amount of foodthe patient can ingest. It also creates a small outlet that slows theemptying process into the stomach and the intestines. According to thecompany's website, patients using the system experience an earliersensation of fullness and are satisfied with smaller amounts of food,which results in weight loss.

A significant drawback of the BioEnterics® LAP-BAND® System is that alaparoscopic incision must be made within the patient's abdomen in orderto place the device. Applicant's co-pending U.S. patent application Ser.No. 10/288,619, which is incorporated herein by reference in itsentirety, and from which the present application claims priority,describes endoluminal methods and apparatus for providing the stomachwith an hourglass profile to facilitate weight loss, thereby mitigatinga need for laparoscopic incisions. In FIG. 43, a system of tools of thepresent invention is used to endoluminally achieve such gastricreduction or remodeling via plicated tissue folds. In the method of FIG.43, only suture is disposed on the exterior of the stomachpost-reduction/remodeling.

In FIG. 43A, a plurality of tissue folds F have been formed around thecircumference of stomach S within an upper portion of the stomach via asystem of tools comprising plication apparatus 10, a plurality of anchorassemblies 60 interconnected by suture 39, multi-fire anchor deliverysystem 500, shape-lockable apparatus 1000 and gastroscope 1100. In FIG.43B, the interconnected anchor assemblies have been cinched together,thereby approximating the plurality of tissue folds F, and endoluminallyproviding stomach S with an hourglass profile. The system of tools maythen be removed from the patient, thereby completing endoluminalreduction or remodeling of stomach S.

In FIGS. 40-42, as an alternative to using anchor delivery system 250 ofFIG. 21, a multi-fire anchor delivery system, such as anchor deliverysystem 500, 500′ or 600 of FIGS. 25-27 (loaded, for example, withmultiple anchor assemblies 60 of FIG. 7), may be used so as to omit aneed to remove and reload all or a portion of the anchor delivery systemfrom the patient's GI lumen in order to deploy and secure multipleanchor assemblies across one or more tissue folds. Furthermore, althoughthe methods of FIGS. 40-43 have illustratively been described withreference to a system of tools comprising plication apparatus 10, anchorassembly 60, anchor delivery system 250 (delivery system 500 in FIG.43), shape-lockable apparatus 1000 and gastroscope 1100, any combinationof diagnostic or therapeutic tools/instruments in accordance with thepresent invention may be utilized, including, for example, alternativeplication apparatus, anchor assemblies, anchor delivery systems andshape-lockable apparatus described previously. Furtherstill, althoughthe visualization element described in FIGS. 40-43 comprises anendoscope or gastroscope, it should be understood that any otheralternative or additional methods or apparatus for visualizing a medicalprocedure may be provided, including, but not limited to, magneticresonance imaging, ultrasound imaging, optical coherence tomographyimaging, fluoroscopic imaging, and combinations thereof. Also, althoughthe system of tools have illustratively been described as advancedthrough shape-lockable apparatus 1000, it should be understood that anyor all of the tools alternatively or additionally may be coupled toapparatus 1000, for example, to distal region 1003 of apparatus 1000.

FIGS. 40-43 have presented methods of using apparatus of the presentinvention to perform endoluminal gastric reduction and treatment ofGERD. Alternative methods for performing these medical procedures usingapparatus of the present invention will be apparent to those of skill inthe art. For example, U.S. Pat. No. 6,540,789 to Silvermann et al.,which is incorporated herein by reference, describes a method forperforming gastric reduction by injecting bulking agents into apatient's stomach at a plurality of locations, thereby reducing a volumeof the stomach. Apparatus of the present invention may be used to reducethe volume of a patient's stomach by forming a plurality of securedtissue folds within the stomach. The tissue folds may be formed, forexample, at a plurality of randomly selected locations. Alternatively,apparatus of the present invention may be used to perform gastricreduction via placement and/or sizing of an implantable stoma within thestomach. As yet another example, marking devices may be provided withapparatus of the present invention in order to map out locations forformation of tissue folds, e.g., to achieve gastric reduction.Additional methods will be apparent.

Apparatus of the present invention should in no way be construed aslimited to treatment of GERD or morbid obesity. Rather, a variety ofother medical procedures—both diagnostic and therapeutic, or acombination thereof—may be performed within a patient's gastrointestinallumen or other body cavities or organs, including hollow, tortuousand/or unpredictably supported body cavities, using tools andinstruments of the present invention. These include, but are not limitedto, endoscopic retrograde cholangiopancreatography (“FRCP”), intubationof the bile duct, upper or lower gastrointestinal endoscopy,colonoscopy, flexible sigmoidoscopy, esophageal dilatation, anastomosis,liver biopsy, esophageal manometry, esophageal pH, cholecystectomy,enteroscopy, resection of lesions or early cancers, treatment ofbleeding sites, trans-esophageal microsurgery, trans-anal microsurgery,and combinations thereof. Additional procedures will be apparent tothose of skill in the art.

With reference to FIG. 44, an exemplary method of resecting a lesion orearly cancer, e.g. within a patient's gastrointestinal tract, usingapparatus of the present invention is described. In FIG. 44, system oftools 3000 comprises shape-lockable overtube 1000 having suctionplicator 1500 coupled to its distal end. System 3000 further comprisesendoscope 1100 and tool delivery tube 1600 disposed within lumen 1005 ofovertube 1000. Tool delivery tube 1600 optionally may comprise deliverytube 252 of anchor delivery system 250, as described hereinbelow withrespect to FIG. 45, or may comprise the delivery tube of any alternativeanchor delivery system described previously. Furthermore, tube 1600 maybe coupled to overtube 1000 or may advanceable relative to the overtube.

Suction plicator 1500 comprises side aperture 1510 to facilitateside-suction plication of tissue. Plicator 1500 additionally oralternatively may comprise one or more apertures at its distal end (notshown) to facilitate end-suction plication of tissue. Plicator 1500 andovertube 1000 preferably are sealed along their lengths, such thatsuction may be drawn through the overtube and plicator, e.g., via asuction pump (not shown) coupled to a proximal region of overtube 1000external to the patient.

Advantageously, as compared to previously-known suction plicationapparatus, shape-lockable overtube 1000 allows system of tools 3000 tobe positioned at a treatment site while the overtube is disposed in aflexible state. Overtube 1000 then optionally may be transitioned to arigid state prior to drawing of suction through plicator 1500. In thismanner, system 3000 may be directed to, and maintained at, a treatmentsite during a medical procedure.

In FIG. 44, shape-lockable overtube 1000 has been endoscopicallyadvanced, e.g., through a patient's esophagus or colon, under endoscopicvisualization provided by endoscope 1100, to a vicinity of lesion orearly cancer C along tissue wall W, while the overtube was disposed in aflexible state. Overtube 1000 alternatively may be advancedlaparoscopically, e.g. through a trocar. The overtube preferably is thentransitioned to a rigid state in a configuration enabling access, e.g.luminal access, to the lesion or early cancer.

Suction is drawn through overtube 1000 and suction plicator 1500 to urgetissue in the vicinity of lesion/early cancer C through side aperture1510 and into lumen 1005 of overtube 1000, thereby forming tissue foldF. As can be verified by endoscopic visualization, lesion or cancer Cresides on the folded tissue. The lesion, polyp, cancer, etc. then maybe removed via cutting apparatus, such as snare or resection loop 1700advanced through tool delivery tube 1600. As will be apparent to thoseof skill in the art, alternative plication apparatus in accordance withthe present invention may be used to resect lesion C.

With reference now to FIG. 45, an exemplary method for endoscopicallytreating a bleeding site, e.g. within a patient's gastrointestinaltract, is described. In FIG. 45, system of tools 3000′ is substantiallythe same as system 3000 of FIG. 44, except that tool delivery tube 1600′illustratively comprises delivery tube 252 of anchor delivery system of250, and resection loop 1700 illustratively has been replaced withanchor delivery system 250 and anchor assembly 60 for securing tissuefolds drawn through side-aperture 1510 of suction plicator 1500. System3000′ has been positioned, and tissue fold F has been formed, utilizingthe techniques described hereinabove with respect to FIG. 44, such thatbleeding site B resides on folded tissue F. Anchor delivery system 250having needle 260 is then actuated in the manner described previously todeploy and adjust anchor assembly 60 and secure tissue fold F, therebysealing and precluding additional bleeding from bleeding site B.

As will be apparent to those of skill in the art, alternative plicationapparatus and/or anchor delivery systems in accordance with the presentinvention may be used to treat bleeding site B. Furthermore, althoughtool systems 3000 and 3000′ of FIGS. 44 and 45, respectively, haveillustratively been described for use in resecting lesions and/ortreating bleeding sites, these systems alternatively or additionally maybe used for any other applicable medical procedure, including, but notlimited to, those described previously, such as gastric reduction andtreatment of gastroesophageal reflux disease.

Although preferred illustrative embodiments of the present invention aredescribed hereinabove, it will be apparent to those skilled in the artthat various changes and modifications may be made thereto withoutdeparting from the invention. It is intended in the appended claims tocover all such changes and modifications that fall within the truespirit and scope of the invention.

1. An endoscopic apparatus, comprising: an elongate endoscopic devicehaving a proximal end, a distal end, and a length therebetween, whereinat least a portion of the length is adapted to lock its configuration;an end effector positioned at the distal end of the endoscopic device,the end effector having an outer surface and being provided with atleast one recess opening onto the outer surface and an internalpassageway communicating with the recess whereby when a suction sourceis coupled to the endoscopic device a suction is created in the recessto draw a portion of tissue wall into the recess; and a needle slidablydisposed in the endoscopic device, the needle being actuatable from aproximal end of the needle for movement from a retracted position inwhich a distal end of the needle is out of the recess to an extendedposition in which the distal end of the needle extends into the recesswhereby the needle can be extended into the portion of tissue wall drawninto the recess.
 2. The apparatus of claim 1 wherein the endoscopicdevice has a lumen extending from the proximal end to the distal end,the suction source being coupled to the lumen in a vicinity of theproximal end of the endoscopic device.
 3. The apparatus of claim 1wherein the endoscopic device has a lumen extending from the proximalend to the distal end, the needle being slidably disposed in the lumen.4. The apparatus of claim 1 wherein the endoscopic device is comprisedof a plurality of adjacent links.
 5. The apparatus of claim 1 whereinthe endoscopic device is adapted to have an endoscope advanced throughthe internal passageway.
 6. The apparatus of claim 1 further comprisingan endoscopic visualization device adapted to be advanced within theinternal passageway.
 7. The apparatus of claim 1 wherein the needle ispositioned proximally of the recess when in the retracted position. 8.The apparatus of claim 1 further comprising an anchor assembly adaptedto be deployed via the needle through the tissue wall drawn into therecess.
 9. A method of forming a tissue fold, comprising: positioning adistal end of an elongate endoscopic device relative to a portion oftissue wall, the endoscopic device having a length adapted to lock itsconfiguration; drawing tissue into at least one recess opening definedon an outer surface of an end effector positioned at the distal end ofthe endoscopic device; advancing a needle slidably disposed in theendoscopic device from a retracted position in which a distal end of theneedle is out of the recess to an extended position in which the distalend of the needle extends into the recess; and securing the portion oftissue wall drawn into the recess.
 10. The method of claim 9 whereinpositioning a distal end of an elongate endoscopic device comprisesadvancing the endoscopic device into a stomach of a patient.
 11. Themethod of claim 9 wherein drawing tissue into at least one recessopening comprises pulling the portion of tissue wall into the recessopening via a suction force.
 12. The method of claim 9 wherein advancinga needle comprises manipulating a proximal end of the needle such thatits distal end is advanced from a position proximal of the recessopening.
 13. The method of claim 9 wherein advancing a needle furthercomprises piercing the portion of tissue wall within the recess openingvia the needle.
 14. The method of claim 9 wherein securing the portionof tissue wall comprises deploying an anchor assembly against the tissuesuch that a configuration of the tissue wall is maintained.
 15. A tissuesuturing system, comprising: an endoscopic sheath adapted to have aflexible state and a rigid state, a distal portion of the endoscopicsheath defining a side opening and a lumen through which an endoscope isadvanceable; a needle disposed in the endoscopic sheath and adapted tomove from a first position to a second position; and a suction deviceadapted to create a negative pressure on an interior of the endoscopicsheath to suck tissue through the opening to an interior of the opening.16. The system of claim 15 further comprising an endoscope foradvancement through the endoscopic sheath.
 17. The system of claim 16further comprising at least one tool having an end effector adapted foradvancement through the endoscope.
 18. The system of claim 15 furthercomprising an anchor assembly adapted to be deployed into or against thetissue via the needle.
 19. The system of claim 15 wherein the lumenextends from a proximal portion to the distal portion and is in fluidcommunication with the side opening.
 20. The system of claim 19 whereinthe suction device is fluidly coupled to the lumen at the proximalportion.
 21. The system of claim 15 wherein the endoscopic sheathdefines a needle lumen extending from a proximal portion to the distalportion, wherein the needle is slidably disposed within the needlelumen.
 22. The system of claim 15 wherein the endoscopic sheath iscomprised of a plurality of adjacent links.
 23. The system of claim 15further comprising an endoscopic visualization device adapted to beadvanced within the lumen.
 24. The system of claim 15 wherein the needleis positioned proximally of the side opening when in the first position.25. The system of claim 24 wherein the needle is positioned within ordistally of the side opening when in the second position.
 26. A methodof manipulating tissue, comprising: advancing a distal portion of anendoscopic sheath to a tissue region, the endoscopic sheath having alength adapted to have a flexible state and a rigid state; positioning aside opening defined in the distal portion relative to the tissueregion, the side opening being in fluid communication with a lumendefined through the endoscopic sheath; drawing the tissue region intothe side opening; and piercing the tissue region within the side openingwith a needle disposed within the endoscopic sheath.
 27. The method ofclaim 26 wherein advancing a distal portion of an endoscopic sheathcomprises advancing the endoscopic sheath into a stomach of a patient.28. The method of claim 26 further comprising positioning an endoscopewithin the endoscopic sheath proximal of the side opening prior topiercing the tissue region within the side opening.
 29. The method ofclaim 26 wherein drawing the tissue region comprises pulling the tissueregion into the side opening via a suction force.
 30. The method ofclaim 26 wherein piercing the tissue region comprises manipulating aproximal end of the needle such that its distal end is advanced from aposition proximal of the side opening.
 31. The method of claim 26further comprising securing the tissue region such that the tissuemaintains a folded configuration.
 32. The method of claim 31 whereinsecuring the tissue region comprises deploying an anchor assemblyagainst the tissue such that a configuration of the tissue wall ismaintained.